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A randomized, double-blind, double dummy, multi-center clinical trial, taking Pinaverium Bromide Tablets as parallel control, to evaluate the function characteristics of Bupiyichang pill in improving diarrhea-predominant irritable bowel clinical syndrome

A randomized, double-blind, double dummy, multi-center clinical trial, taking Pinaverium Bromide Tablets as parallel control, to evaluate the function characteristics of Bupiyichang pill in improving diarrhea-predominant irritable bowel clinical syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008365
Enrollment
Unknown
Registered
2016-04-26
Start date
2012-10-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS-D

Interventions

Study group ?:Bupiyichang pills, horse-dimensional sheet mimetic bromide
Study group ?:Pinaverium bromide tablets, pills simulant Bupiyichang
Study group ?:Bupiyichang pills, pinaverium bromide tablets

Sponsors

Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The subjects who were confirmed as Diarrheic type Irritable Bowel Syndrome(IBS-D) by western medicine diagnostic criteria (For subjects whos condition has already stable after accepted non-medication treatment such as diet and life conditioning); (2) The average of each days highest stomachache score(0~10 pain rating scale) in one week >3.0; the stools type is 6 or 7 by Bristol stool score, and the situation should happen no less than 2 days in one week[6]; (3) Between 18 and 65 years old, genders unlimited; (4) Accepted the medications treatment voluntarily and sign informed consent which process conforms to GCPs relevant regulation.

Exclusion criteria

Exclusion criteria: (1) IBS-D patient who has syndrome of dampness-heat in the spleen and stomach such as yellow and slimy tongue fur and burning pain in anus; (2) Confirmed as infectious diarrhea, inflammatory bowel disease, parasitic infection, positive in occult blood test, Colorectal tumor, malabsorption syndrome, lactose intolerance(combined with medical history) and diarrhea caused by systemic disease by examination; (3) Non-IBS-D patient or patient with other digestive systems organic disease, or stomachache and discomfort in abdominal caused by other organic disease; (4) Patient who concomitants with cardiovascular disease, cerebrovascular disease, liver disease, kidney disease, hematopoietic system disease, hyperthyroidism, diabetes and other serious primary disease or severe disease which can affect patients survival(such as tumor) and psychopath; (5) Women who have known or prepare to pregnancy and women during breast feeding period; (6) Patient who is allergic constitution, allergic to various food and medicine or allergic to the study medication(Bupiyichang pill, Pinaverium Bromide Tablets) and their components; (7) Suspected or confirmed with alcohol or drug abuse history; (8) Inform consent cannot be signed because of cognitive impairment; (9) Patient who used IBS treatment medicine within the last two weeks and was included in other clinical trial within the last one month; (10) Patient who is inappropriate according to the investigator.

Design outcomes

Primary

MeasureTime frame
Abdominal pain (Degree);Diarrhea (Frequency);Then quality (Characters);

Secondary

MeasureTime frame
Quality of life score;

Countries

China

Contacts

Public ContactZhang Shengsheng

Beijing Chinese Medicine Hospital affiliated to Capital Medical University

zhss2000@163.com+86 010-52176634

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026