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Study protocol
Efficacy of Tong-Xie-Yao-Fang granule and its impact on whole transcriptome profiling in diarrhea-predominant irritable bowel syndrome patients: study protocol for a randomized controlled trial
Fengbin Liu
Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-8957-9260
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Irritable bowel syndrome (IBS) is one kind of common functional bowel disease with obscure pathogenesis and exploration about whole transcriptome profiling in IBS-D is still negligible. Conventional medications have limited effects, which makes focus shifted to traditional Chinese medicine (TCM). Tong-Xie-Yao-Fang, as a classic herbal formula in TCM, is pretty effective and safe for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), but the underlying therapeutic mechanism remains unknown. We aim to verify the efficacy and safety of TXYF granule (the formula particles mixed together) in IBS-D and elucidate the gene-level mechanism of IBS-D and therapeutic targets of TXYF granule based on whole transcriptome analysis.
Methods/design: This is a randomized, double-blind and placebo-controlled clinical trial consisting of 2 weeks run-in period, 12 weeks treatment period and 8 weeks follow-up period. We will enroll 120 participants with IBS-D, who will be randomly assigned to TXYF granule group and the placebo group and recruit additional 10 healthy individuals as controls for mechanistic outcome. The two groups respectively take TXYF granule or placebo orally for treatment. The primary outcome is the response rate of IBS-Symptom Severity Score (IBS-SSS). The secondary outcomes include adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL) and long-term efficacy. Mechanistic outcome is the whole transcriptome profiling of the intestinal mucosae from IBS participants before and after the treatment and healthy individuals.
Discussion: This trial will prove the effectiveness and safety of TXYF granule with high-quality evidence and provide a penetrating and comprehensive perspective on the molecular mechanism of IBS-D by whole transcriptome analysis, which makes us pinpoint specific biomarkers of IBS-D and therapeutic targets of TXYF.
Keywords
Diarrhea-predominant irritable bowel syndrome, whole transcriptome profiling, Tong-Xie-Yao-Fang granule, randomized controlled trial, traditional Chinese medicine
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CURRENT STATUS: Published
Version 2
Posted 17 Sep, 2020
Published
On 03 Nov, 2020
No community comments so far
Editorial decision: Accept
On 20 Oct, 2020
Review #2 received
Received 16 Oct, 2020
Reviewer #2 agreed
On 14 Oct, 2020
Review #1 received
Received 21 Sep, 2020
Reviewer #1 agreed
On 17 Sep, 2020
Editor assigned
On 16 Sep, 2020
Reviewers invited
Invitations sent on 16 Sep, 2020
Submission checks complete
On 15 Sep, 2020
No comments provided
Editorial decision: Major revision
On 10 Aug, 2020
Review #1 received
Received 02 Aug, 2020
Review #2 received
Received 01 Aug, 2020
Reviewer #1 agreed
On 21 Jul, 2020
Reviewer #2 agreed
On 21 Jul, 2020
Reviewers invited
Invitations sent on 20 Jul, 2020
Editor assigned
On 18 Jul, 2020
Submission checks complete
On 13 Jun, 2020
First submitted
On 02 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Efficacy of Tong-Xie-Yao-Fang granule and its impact on whole transcriptome profiling in diarrhea-predominant irritable bowel syndrome patients: study protocol for a randomized controlled trial
Fengbin Liu
Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-8957-9260
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 17 Sep, 2020
Published
On 03 Nov, 2020
No community comments so far
Editorial decision: Accept
On 20 Oct, 2020
Review #2 received
Received 16 Oct, 2020
Reviewer #2 agreed
On 14 Oct, 2020
Review #1 received
Received 21 Sep, 2020
Reviewer #1 agreed
On 17 Sep, 2020
Editor assigned
On 16 Sep, 2020
Reviewers invited
Invitations sent on 16 Sep, 2020
Submission checks complete
On 15 Sep, 2020
No comments provided
Editorial decision: Major revision
On 10 Aug, 2020
Review #1 received
Received 02 Aug, 2020
Review #2 received
Received 01 Aug, 2020
Reviewer #1 agreed
On 21 Jul, 2020
Reviewer #2 agreed
On 21 Jul, 2020
Reviewers invited
Invitations sent on 20 Jul, 2020
Editor assigned
On 18 Jul, 2020
Submission checks complete
On 13 Jun, 2020
First submitted
On 02 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Irritable bowel syndrome (IBS) is one kind of common functional bowel disease with obscure pathogenesis and exploration about whole transcriptome profiling in IBS-D is still negligible. Conventional medications have limited effects, which makes focus shifted to traditional Chinese medicine (TCM). Tong-Xie-Yao-Fang, as a classic herbal formula in TCM, is pretty effective and safe for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), but the underlying therapeutic mechanism remains unknown. We aim to verify the efficacy and safety of TXYF granule (the formula particles mixed together) in IBS-D and elucidate the gene-level mechanism of IBS-D and therapeutic targets of TXYF granule based on whole transcriptome analysis.
Methods/design: This is a randomized, double-blind and placebo-controlled clinical trial consisting of 2 weeks run-in period, 12 weeks treatment period and 8 weeks follow-up period. We will enroll 120 participants with IBS-D, who will be randomly assigned to TXYF granule group and the placebo group and recruit additional 10 healthy individuals as controls for mechanistic outcome. The two groups respectively take TXYF granule or placebo orally for treatment. The primary outcome is the response rate of IBS-Symptom Severity Score (IBS-SSS). The secondary outcomes include adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL) and long-term efficacy. Mechanistic outcome is the whole transcriptome profiling of the intestinal mucosae from IBS participants before and after the treatment and healthy individuals.
Discussion: This trial will prove the effectiveness and safety of TXYF granule with high-quality evidence and provide a penetrating and comprehensive perspective on the molecular mechanism of IBS-D by whole transcriptome analysis, which makes us pinpoint specific biomarkers of IBS-D and therapeutic targets of TXYF.
Figure 1
Figure 2