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The Effect of Chinese Herb Solid Drink, a Traditional Chinese Medicine Diet Formula, on Functional Constipation and Gut Microbiota

Phase 1
Conditions
Functional constipation
Registration Number
ITMCTR2000003207
Lead Sponsor
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Aged >= 18 years;
2. There are 2 or more of the following symptoms: difficulty in defecation, dry ball feces, incomplete feeling of defecation, manual assistance in defecation, defecation less than 3 times a week;
3. Meeting the syndrome differentiation of traditional Chinese Medicine of intestinal dryness and fluid deficiency.
4. Patients must stop taking drugs for constipation for at least 1 week before being enrolled;
5. Volunteer to participate in the study, adhere to the treatment according to the doctor's orders, and make regular follow-up, with good compliance.

Exclusion Criteria

1. Patients with serious diseases of vital organs such as lung, heart, kidney, liver and brain or psychosis;
2. Previous gastrointestinal surgery or organic lesions of rectum and colon (such as intestinal tumor, Crohn's disease, intestinal tuberculosis, etc.);
3. Patients with allergic constitution or presence of allergy to test drug ingredients;
4. Patients participate in other clinical trials during the treatment;
5. Pregnant or lactating women.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Patient-Assessment of Constipation Quality Of Life;Defecation frequency;Difficulty in defecation;stool texture;
Secondary Outcome Measures
NameTimeMethod
Abdominal distention and pain;appetite;
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