Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multi-center, Randomized, Double-blind, Placebo Controlled Clinical Trial

2021 ◽  
Author(s):  
Ya Zheng ◽  
Jessica Ching ◽  
Chung-wah Cheng ◽  
Wai-ching Lam ◽  
Kam-Leung Chan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Chinese Medicine ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Irritable Bowel

Abstract Background: Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant Irritable bowel syndrome (IBS-D). Chinese Herbal Medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD).Methods: This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with two-week run-in, eight-week treatment and eight-week follow-up. After run-in period, participants will be randomized to receive either JCM-16021 or placebo for eight weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the Global Assessment of Improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. Results: A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine.Conclusion: The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese Medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol.Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1

scholarly journals Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ya Zheng ◽  
Jessica Ching ◽  
Chung Wah Cheng ◽  
Wai Ching Lam ◽  
Kam Leung Chan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Chinese Medicine ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Irritable Bowel

Abstract Background Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD). Methods This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. Results A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine. Conclusion The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol. Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1

Efficacy and safety of Trang Phuc Linh Plus tablets in patients with irritable bowel syndrome-diarrhea

2021 ◽  
Vol 148 (12) ◽  
pp. 68-77
Author(s):  
Pham Thi Van Anh ◽  
Nguyen Phuong Thanh ◽  
Dau Thuy Duong ◽  
Nguyen Thi Thuy ◽  
Dang Thi Ngoc Mai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Group I ◽  
Randomized Phase Ii ◽  
Irritable Bowel ◽  
Diarrhea Syndrome ◽  
Symptom Recurrence

A double-blind, randomized, phase II clinical trial was conducted within a 14-week follow-up including 2 weeks of the non-drug run-in period, 8 weeks of medication, and 4 weeks of follow-up after discontinuation. The objective of the study was to evaluate the efficacy and safety of Trang Phuc Linh Plus in irritable diarrhea syndrome patients. Group I took Trang Phuc Linh Plus 3 tablets/time x 2 times/day for 8 weeks; Group II took placebo 3 tablets/time x 2 times/day for 8 weeks. Patients will be re-examined, tested, and evaluated over the phone for symptom recurrence and adverse events (AEs). This study showed that the Trang Phuc Linh Plus tablets tended to improve symptoms in patients suffering from irritable bowel syndrome with diarrhea, suggesting its safety and tolerability.

Efficacy and safety of a dieckol-rich extract (AG-dieckol) of brown algae, Ecklonia cava, in pre-diabetic individuals: a double-blind, randomized, placebo-controlled clinical trial

2015 ◽  
Vol 6 (3) ◽  
pp. 853-858 ◽  
Author(s):  
Seung-Hong Lee ◽  
You-Jin Jeon
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Brown Algae ◽  
Ecklonia Cava ◽  
Controlled Clinical Trial ◽  
Diabetic Patients ◽  
Efficacy And Safety ◽  
Double Blind

A dieckol-rich extract (AG-dieckol) is a promising anti-diabetic agent or pharmaceutical resource that helps to improve the quality of life for diabetic patients.

scholarly journals Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Ghasem Bordbar ◽  
Mohammad Bagher Miri ◽  
Mahmoud Omidi ◽  
Saeed Shoja ◽  
Malihe Akhavan
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Herbal Medicine ◽  
Essential Oils ◽  
Herbal Remedies ◽  
Control Group ◽  
Efficacy And Safety ◽  
Irritable Bowel

Background. The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, Zataria multiflora Boiss (ZM), Trachyspermum ammi L. (TA), and Anethum graveolens L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combination of ZM, AG, and TA essential oils in the treatment of IBS. Method. The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in the control arm received three tablets of 10 mg hyoscine butylbromide daily for two weeks, and the intervention arm was daily treated with two 250 mg softgel capsules containing 180 mg of essential oils of ZM, AG, and TA for two weeks. Primary outcomes were the response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI) at the end and two weeks after the end of the intervention. Secondary outcomes were the improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability. Results. The posttreatment improvement percentage based on IBS-AR, IBS-GAI, and IBS-SSS scales was 83.9%, 75%, and 87% in the intervention group and 37.9%, 27.5%, and 34.4% in the control group, respectively (P<0.001). Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm (P<0.001). Conclusions. According to the results, the herbal medicine investigated in this study can be considered an appropriate alternative treatment for IBS.

scholarly journals Efficacy of Lactobacillus paracasei HA-196 and Bifidobacterium longum R0175 in Alleviating Symptoms of Irritable Bowel Syndrome (IBS): A Randomized, Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1159 ◽  
Author(s):  
Erin D. Lewis ◽  
Joseph M. Antony ◽  
David C. Crowley ◽  
Amanda Piano ◽  
Renu Bhardwaj ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Bifidobacterium Longum ◽  
Well Being ◽  
Lactobacillus Paracasei ◽  
Controlled Study ◽  
Double Blind ◽  
Gi Symptoms ◽  
Irritable Bowel

Specific probiotic strains can alleviate the gastrointestinal (GI) symptoms and psychiatric comorbidities of irritable bowel syndrome (IBS). In this randomized, double-blind, placebo-controlled study, the efficacy of Lactobacillus paracasei HA-196 (L. paracasei) and Bifidobacterium longum R0175 (B. longum) in reducing the GI and psychological symptoms of IBS was evaluated in 251 adults with either constipation (IBS-C), diarrhea (IBS-D), or mixed-pattern (IBS-M). Following a 2-week run-in period, participants were randomized to one of three interventions: L. paracasei (n = 84), B. longum (n = 83) or placebo (n = 81). IBS symptoms, stool frequency and consistency and quality of life were assessed by questionnaires. The differences from baseline in the severity of IBS symptoms at 4 and 8 weeks were similar between groups. Participants in this study were classified, after randomization, into subtypes according to Rome III. Within the L. paracasei group, complete spontaneous and spontaneous bowel movement frequency increased in participants with IBS-C (n = 10) after 8 weeks of supplementation (both p < 0.05) and decreased in participants with IBS-D (n = 10, p = 0.013). Both L. paracasei and B. longum supplementation improved the quality of life in emotional well-being and social functioning compared with baseline (all p < 0.05). In conclusion, L. paracasei and B. longum may reduce GI symptom severity and improve the psychological well-being of individuals with certain IBS subtypes.

scholarly journals A Low-FODMAP Diet for Irritable Bowel Syndrome: Some Answers to the Doubts from a Long-Term Follow-Up

Nutrients ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 2360 ◽  
Author(s):  
Massimo Bellini ◽  
Sara Tonarelli ◽  
Federico Barracca ◽  
Riccardo Morganti ◽  
Andrea Pancetti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Nutritional Adequacy ◽  
Related Quality ◽  
Short And Long Term ◽  
Irritable Bowel ◽  
Fodmap Diet

A low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet (LFD) is a possible therapy for irritable bowel syndrome (IBS). This study investigates the short- and long-term efficacy and nutritional adequacy of an LFD and the patients’ long-term acceptability. Patients’ adherence and ability to perceive the “trigger” foods were also evaluated. Seventy-three IBS patients were given an LFD (T0) and after 2 months (T1), 68 started the reintroduction phase. At the end of this period (T2), 59 were advised to go on an Adapted Low-FODMAP Diet (AdLFD) and 41 were evaluated again after a 6–24 month follow-up (T3). At each time, questionnaires and Biolectrical Impedance Vector Analysis (BIVA) were performed. The LFD was effective in controlling digestive symptoms both in the short- and long-term, and in improving quality of life, anxiety and depression, even if some problems regarding acceptability were reported and adherence decreased in the long term. The LFD improved the food-related quality of life without affecting nutritional adequacy. When data collected at T0 were compared with those collected at T2, the perception of trigger foods was quite different. Even if some problems of acceptability and adherence are reported, an LFD is nutritionally adequate and effective in improving IBS symptoms also in the long term.

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