Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen

NCT ID: NCT04454996

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2022-03-30

Brief Summary

To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.

Conditions

Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Non-erosive reflux disease test group

Group Type: EXPERIMENTAL

tong-jiang granules

Intervention Type: DRUG

This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.

Non-erosive reflux disease control group

Group Type: PLACEBO_COMPARATOR

The placebo of tong-jiang granules

Intervention Type: DRUG

This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.

Diarrhea-type irritable bowel syndrome test group

Group Type: EXPERIMENTAL

Chang 'an II Recipe

Intervention Type: DRUG

This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.

Control group with diarrheal irritable bowel syndrome

Group Type: PLACEBO_COMPARATOR

The placebo of Chang 'an II Recipe

Intervention Type: DRUG

This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.

Healthy control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

tong-jiang granules

This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.

Intervention Type: DRUG

Chang 'an II Recipe

This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.

Intervention Type: DRUG

The placebo of tong-jiang granules

This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.

Intervention Type: DRUG

The placebo of Chang 'an II Recipe

This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy volunteers with no abnormal clinical manifestations;

2. Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency.

3. Aged between 18 and 70.

4. Did not take antibiotics, steroids or other hormones, Chinese herbal preparations (including oral and intravenous administration), microecological preparations or probiotics such as yogurt for nearly a week;

5. Subjects are informed and sign informed consent voluntarily;

6. Have certain reading ability.

Exclusion Criteria

1. Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases;

2. Complicated with other organic diseases of the digestive system (such as peptic ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as hyperthyroidism and diabetes);

3. Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.);

4. Those with a history of allergy to related drugs or severe food allergy used in the research.

5. The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiyuan Hospital of China Academy of Chinese Medical Science

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

lin lv

Role: CONTACT

lushangshitou@qq.com

18811782728

Facility Contacts

lin lv

Role: primary

lushangshitou@qq.com

18811782728

Other Identifiers

ZZ13-ZD-02

Identifier Type: -

Identifier Source: org_study_id