CHARACTERISTICS OF STUDIES
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Reference
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Study design
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N; mean age (years)
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Disease
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Intervention (name; dosage or frequency; duration)
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Outcome measures
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Findings and comments
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Side Effects
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Afshan Begam et al.
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Comparative Clinical Trial
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68 11 to 70 years
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Signs and symptoms of Vatarakta
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Group 1-Aswath Kasaya Dosage-40 ml bd Duration-90 days Group 2-Guduchi Kashaya Dosage-40 ml bd Duration-90 days Group 3-Combined group –Aswath Guduchi Kashaya Dosage-40 ml bd Duration-90 days
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Subjective Criteria-Pain index Objective criteria-Serum uric acid
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Group 3 is more effective
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Not reported
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Adithya Acharya K et al.
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Comparative Clinical Trial
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40 20-65 years
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Hyperuricemia, less than 10 year’s chronicity, without manifestation of tophi and joint destruction.
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Group A-Siravyadha/ bloodletting twice with an interval of 11 days. Follow up on 24 th day Group B-Guduchi siddha yogabasti in 8 days Follow up on 24 th day
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Subjective parameters- Pricking pain (Sandhi toda), Tenderness (Sparshasahyata), Redness (Raga), Swelling (Sandhishotha), Sandhi Supti (Numbness of joints), Objective parameters Serum Uric acid
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Subjective parameters- In Group A Pricking pain (Sandhi toda) relieved rapidly, but in group B gradual relieved . Tenderness (Sparshasahyata)- highly significant result in group B, Redness (Raga)-Early relief observed in Group A than group B, Swelling (Sandhishotha) Early relief observed in Group A than group B, Sandhi Supti (Numbness of joints) Early relief observed in Group A than group B, Overall response was marked in Group A (35%) than Group B (0 %) Objective parameters Serum Uric acid Group B (21 %) showed more reduction in serum uric acid compared to group A (13.33%).
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Not reported
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Vishwajeet Manjhi et al.
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Randomised open comparative clinical trial
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45 20-60 years
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Elevated serum uric acid level > 6.8 mg/dl, Vatarakta
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Group A – Amritadi Kashaya 80 ml bd in empty stomach with 10 ml castor oil for 16 days. Group B- Ardhamatrika basti as per Kalabasti schedule (16 days) Group C- combined group for 16 days.
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Subjective criteria-Signs and symptoms of Vatarakta with scoring pattern. Objective parameter- Serum Uric acid
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Group A- 26.75 % were moderately improved, 46.75 % got mild improvement and 26.75 % showed no improvement. Group B-46.75 % got moderate improvement, 53.33 % showed mild improvement and 0 % was in unimproved category. Group C- 73.33 % showed moderate improvement, 26.75 % showed mild improvwmt. No patient showed complete cure in any groups. Objective criteria- Group A showed significant improvement in serum uric acid level, Group B and C showed highly significant improvement.
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Not reported
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Deeika Gupta et al.
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Phase-2 rational randomized (sequential pattern) parallel group study.
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56 21-60 years
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Vatarkata (Gouty arthritis) Having Seum uric acid > 7 mg/dl in males and >5.7 mg/dl in females
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Group A-Patoladi kwath 40 ml bd after food for 90 days Group B-Patoladi kwath 40 ml bd & Rasnadi pradeha (local application) During evening for 90 days.
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Subjective criteria- Sandhishu ruk-pain in affected joint, Sandhishu Raga - Redness , Sandhishu swayathu- Swelling, Sparshasahyata –Tenderness, sandhishu kathinya-decreased / restricted movements, , skin discoloration of affected area, itching on affected part, burning sensation Objective parameter-Serum uric acid, ESR, Hb, TLC, DLC, KFT, LFT, FBS, PPBSassessment done on every fortnight after administration of trial drugs.
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Group A-48% got complete relief, 28% moderately relieved and 20 % got mild improvement and 4 % not responded to treatment. In Group B-76 % got complete relief, 16 % got moderate improvement, 8 % showed mild improvement and no case recorded as unchanged.
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Not reported
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Dr Sharma Parvesh et al.
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30 20-60 years
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Randomised open clinical trial.
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Vatarakta, serum uric acid level 5.5-10 mg/dl.
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Group A-Bodhivriksha twak churn with madhu 3 gm bd Group B-Bodhivriksha twak churn with jala 3 gm bd Duration-45 days
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Pain, tenderness, swelling, stiffness, burning sensation in joints, Hb, serum Uric acid, Serum creatinine, X-Ray, Urine RE and Microscopic examination.
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The study was highly significant (P<0.001) for all subjective parameters, serum uric acid and was insignificant(P>0.05) for Haemoglobin and serum creatinine in group A. In group B, swelling, stiffness, joint pain and serum uric acid showed highly significant results. For tenderness and burning sensation the p value was <0.05 and for haemoglobin and serum creatinine the result was insignificant (P>0.005) in group B.
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Not reported
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H Kuvettu et.al
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A randomized single blind clinical study with pretest and posttest design
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378 20-60 years
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Gouty arthritis
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Group A - 190 patients were administered Amritaguggulu 500 mg 2 tablets thrice daily for 30 days. Group B - 188 patients were administered Kaisoraguggulu 500 mg 2 tablets thrice daily for 30 days. During the study, special diet was followed
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Subjective parameter-The signs and symptoms of gout-burning sensation, pain, swelling, stiffness, mobility, deformity of joints. were assessed. Objective parameters - haemoglobin percentage, ESR and serum uric acid.
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Marked improvement was found for 68% of patients in group A, whereas in group B it was only 42%. The study showed statistically highly significant results for all subjective and objective parameters in both the groups. The study concluded that Amritaguggulu was more effective than Kaisoragugguluin the management of gouty arthritis.
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Not reported
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H Kuvettu et.al
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A randomized single blind clinical study with pre-test and post-test design
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462 20-60 years
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Gouty arthritis
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Group A -234 patients were administered Karma Bastiprepared with for 30 days. Group B - 228 patients were administered Kaisoraguggulu 500 mg 2 tablets thrice daily for 30 days. .
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The signs and symptoms of gout-burning sensation, pain, swelling, stiffness, mobility, deformity of joints were assessed under symptom grade parameter. Objective parameters included, haemoglobin percentage, ESR and serum uric acid.
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Marked improvement was found for 56% of patients in group A, whereas in group B it was only 33%. The study showed statistically highly significant results for all subjective and objective parameters in both the groups. The study concluded that Guduchi Sadhita Grithawas more effective than Kaisoraguggulu in the management of gouty arthritis.
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Not reported
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Mehta Chetan et.al
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Comparative study
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60 16 & 70 years
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Vatarakta.
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Group A-Kokilakshadi Ks with Pippali Churna Group B - Siravyadha (on the dorsum of hand/foot, 2 Angula(Fingers-approx. 4 cm) above the Kṣhipramarma)
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Subjective parameter-The signs and symptoms of vatarakta, VAS, Hb, TC, DC, FBS, Uric acid
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In both groups 33.33 % patients did not get any relief. In group A 30% got mild relief and in group B 56.66 % got mild relief. 33.33 5 got moderate relief in group a and 10 % got moderate relief in group B. In group A 1 patient got complete relief and none got complete relief in group B.
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Not reported
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Dr Vikas Rana et.al(2017)
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Non-randomized-comparative parallelgroup design
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30 20-70 years
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Vatarakta.
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Group 1- 15 patients were administered with Sadya Mrudu Sneha Virechanaof Erand Taila10-50 ml with Ksheerafor 3-5 days for Koshtasuddhi followed by administration of 2 tablets of Punarnnava Amarita Guggulu500 mg with Amrithadi Kvath 24 g as Anupanafor 8 weeks. Group 2 - 15 patients were given only 2 tablets of Punarnnava Amarita Guggulu500 mg with Amrithadi Kvath24 g as Anupanafor 8 weeks.
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The subjective criterias assessed were sandhi soola, sandhi shotha, sparshasahyata, raga, vidaha, twak vaivarnya, stabdata, shithilta, hritspanadan and sandhi vikriti. The objective parameter was serum uric acid.
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In group 1, 80 % got moderate improvement and 20 % got mild improvement. In group B, 20% got marked improvement, 53.3% got moderate improvement and 26.6% got mild improvement. The study found, group 1 and group 2 were equally effective in symptoms like sparshasahyata, raga and shithilta. Sandhi shotha, raga and vidaha were improved to greater extent in group 1, whereas sandhi soola, twak vaivarnya and stabdata were better controlled in group 2.
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No adverse effect was noted during the trial and follow up period in this trial.
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Asok Kumar Panda et.al
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non randomized controlled pilot study
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22 Mean age 47
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Gambheera Vata-Raktadiagnosed as acute gout.
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Study group-12 were treated with leech for 7 days with 4 weeks follow up Control group-10 patients who were not willing to participate in leech application were given local diclofenac application for 7 days
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Pain, joint swelling, joint tenderness, joint erythema, patient’s global assessment to response to therapy and investigator’s global assessment to response to therapy.
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leech application is effective in reducing pain, joint swelling, joint tenderness and joint erythema.
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The statistical assessment used was unclear in this study.
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Dr V Balendu Krishnan et.al (2018)
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Comparative clinical trial wth Pre-test and post-test design
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40 18-60 years
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Gouty arthritis
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Group A-amapachana with Sunti churna, Kalavasti with vasaguluchyadi kashaya and guluchyadi gritha (anuvasana), Moorchita tila taila for abhyanga with mrudu swedana followed by shaman oushadis-punarnnavadi guggulu 2 bid with kokilakshakam kashaya (30-45 ml). Gropu B- amapachana with Sunti churna , snehapana with guduchyadi gritha followed by virechana withNimbamrutadi eranda taila and Moorchita tila taila for abhyanga with mrudu sweda followed by shaman oushadis-rasnaguggulu 2 bid with manjishtadi kashaya (30-45 ml) Follow up-48 days for Group A, 30 days for group B.
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Sandhigraha, Sandhi Shoola, Sandhi Shotha, joint colour, Sparshasahatva and serum uric acid
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Both groups were highly significant in reducing the subjective and objective criteria’s. In group A, the percentage of relief was 77.74% and in group B, it was 56.50%. The study concluded that both the groups were having significant role in gouty arthritis, but Vasti has more contributory effect compared to Virechana. The statistical analysis was also unclear in this study too.
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Not reported
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Harbans Singh et al 2017
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Prospective open-label multicentre study with pre-post design
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100 25-60 years
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Primary gouty arthritis
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Amrita guggulu tab 2 Tab of 500 mg twice daily with luke warm water for 12 weeks and Pinda taila external application on affected joint(s)
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Serum uric acid, QOL, using SF-36, Health Survey Questionnaire, Patient’s Global Assessment scale, Physician’s global assessment scale,VAS, LFT, KFT
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Statistically significant result of Serum uric acid, VAS score, QOL, Patient’s Global Assessment Scale, Physician’s global assessment scale. LFT and KFT were performed at baseline and at the end of the treatment. Though some changes were observed, they were within the normal range.
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Not reported
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Shashank Jha et.al 2014
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Non-comparative trials with pre-post design
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10 20-65 years
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signs and symptoms of Vatarakta and serum uric acid level
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Leech therapy -3 times at intervals of 3 weeks. Treatment schedule:
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Sandhishoola, Sandhishopha, Sandhivaivarna Sandhidaha,Serum uric acid
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Statistically significant result.
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Not reported
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Upadhyaya GP et.al.,2010
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Non-comparative trials with pre-post design
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35 Not mentioned
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signs and symptoms of Vatarakta and serum uric acid level
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Punarnnava Guggulu tab -2 tab (500 mg each) after meals with water for 45 days and follow-up were done for 15 days.
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Subjective criteria-signs and symptoms of Vatarakta Objective criteria-Serum uric acid, ESR, TLC, DLC, Urine routine, and microscopic examination.
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Statistically significant result. Maximum effect was observed in kandu(itching), Sparsasahatva (tenderness). Casts and epithelial cells were found reduced significantly from urine.
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Not reported
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L Prasannakumar et.al
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Non-comparative trials with pre-post design
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5 16-70 years
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signs and symptoms of Vatarakta and serum uric acid level
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Guduchyadi ksheera vasthi as yoga vasthi
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Pain, burning sensation, malaise, sleep, tenderness, oedema, walking ability
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For four patients, uric acid came to normal. No patient got complete relief from symptoms. 20 % remained unchanged.
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Not reported
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Harsh Segal et al., 2018
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Non-comparative trials with pre-post design
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31 20-60 years
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signs and symptoms of Vatarakta (Gout), Serum uric acid level 5.5 to 10.0 mg/dl
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Two grams of powder of Andrographis paniculata thrice daily with water.
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Subjective criteria-Oedema, stiffness, inflammation, itching, heaviness, numbness, piercing pain, fatigue, pallor, thirst, indigestion Objective criteria-serum uric acid
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Except symptom pallor, the p value was either <0.05 or <0.01.
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Sharma Usha et al., 2014
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Non-comparative single blind trials with pre-post design
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30 20-60 years
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signs and symptoms of Vatarakta and serum uric acid level
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Tablet Amrita Guggulu 500 mg thrice daily with anupana of amritadi Kashaya 72 ml.
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Subjective criteria Sandhi shola (pain in joints), Sandhi shotha (swelling in joints), Raga (Redness), Kandu (Pruritis), Vidaha, Twak vaivarnyata, Sparsasahishnuta (tenderness) Objective criteria-Serum uric acid, Hb, TLC, DLC, ESR, RA factor
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Statistically significant result.
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Not reported
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Sharma Usha et al.
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Non-comparative single blind trials with pre-post design
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30 20-60 years
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signs and symptoms of Vatarakta and serum uric acid level(>6 mg/dl)
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Tablet Punarnnava amrita Guggulu 500 mg thrice daily with anupana of amritadi Kashaya 72 ml.
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Subjective criteria Sandhi shola (pain in joints), Sandhi shotha (swelling in joints), Raga (Redness), Kandu (Pruritis), Vidaha, Twak vaivarnyata, Sparsasahishnuta (tenderness) Objective criteria-Serum uric acid, Hb, TLC, DLC, ESR, RA factor
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Statistically significant result.
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Not reported
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Yogita Deepak Khore et.al.
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Pre-post design
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10 20-60 years
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signs and symptoms of Vatarakta and serum uric acid level(>6 mg/dl)
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Virechana with draksha kashaya (40 ml) and eranda taila (40 ml)
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Subjective criteria-Shotha, shola, aaraktata, kathinya, sparshasahatva, daha Objective criteria-Serum uric acid
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60 % relief in stiffness & tenderness, 50 % relief in swelling and pain, uric acid level decreased slightly.
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Not reported
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Sivaprasad Huded et.al
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Randomized single blind study with pre-test post-test design
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20 18-60 years
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Vatarakta, acute gouty arthritis-Hyperuricemia
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Guduchi yoga (aqueous extract of Guduchi and Trapusha) 2 g bid with luke warm water after food for 12 weeks .
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Subjective parameter-Sandhishula, daham, sandhisotha, sparshasahatwam, twaklohita Objective parameter-serum uric acid
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Statistically significant results along with attainmaent of normal serum uric acid and improvement in general well being of the patients.
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Not reported
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Pundapal Amitkumar B et.al
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Single blind trials with pre-post design
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20 16-70 years
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Vatarakta
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Lekhana basti as Kalabasti protocol-16 days Vataraktantaka Rasa-250 mg tds for 30 days.
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Pain, burning sensation, malaise, disturbance of sleep, tenderness, walking ability, peripheral pulse, lipid profile.
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Statistically significant results
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Not reported
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