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The significance of syndrome differentiation on outcome assessment in a randomized controlled trial of traditional Chinese medicine

The significance of syndrome differentiation on outcome assessment in a randomized controlled trial of traditional Chinese medicine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003742
Enrollment
Unknown
Registered
2013-10-23
Start date
2013-11-15
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

Functional constipation

Interventions

Fixed MZRW group:MZRW granules + Dulcolax placebo + additional herbal placebo
Modified MaZiRenWan (MZRW) group:MZRW granules + Dulcolax placebo + additional herbal granules
Dulcolax group:MZRW granules + Dulcolax placebo + additional herb

Sponsors

Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients will be recruited only from those who reported: 1) Aged 18-65 years; 2) Fulfill the diagnosis of FC; 3) Fulfill the diagnosis of excessive heat constipation; 4) less than three complete spontaneous bowel movements (CSBMs) per week; 5) Normal colonic examination (barium enema or colonoscopy) within 12 months; 6) Normal liver and renal function.

Exclusion criteria

Exclusion criteria: Patients will be excluded with any of the followings: 1) Secondary constipation (e.g. drug induced constipation, constipation after abdominal surgery, etc); 2) Severe organic diseases; 3) History of Chinese medicine allergy; 4) Women in pregnant or lactating; 5) Psychiatric patients

Design outcomes

Primary

MeasureTime frame
number of complete spontaneous bowel movement (CSB;

Secondary

MeasureTime frame
number of CSBM per week during follow-up;overall constipation assessment;constipation related symptoms assessment;TCM syndromes and their changing patterns;defecation frequency;stool type;use of rescue enem;

Countries

China

Contacts

Public ContactZhaoxiang Bian

School of Chinese Medicine, Hong Kong Baptist University

bianzxiang@gmail.com+86 022-27493265

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026