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A Randomized Controlled Trial of Jibei Haiwa Decoction in the Treatment of Gastroesophageal Reflux Disease

A Randomized Controlled Trial of Jibei Haiwa Decoction in the Treatment of Gastroesophageal Reflux Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002463
Enrollment
Unknown
Registered
2025-12-24
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Gastroesophageal Reflux Disease

Interventions

Western medicine group:Esomeprazole Enteric - coated Tablets (Approval Number:H20203298
Manufacturer: Jiangxi Shanxiang Pharmaceutical Co., Ltd.
Model Specification: 20mg/tablet * 28 tablets/box). Take 20mg each time, twice a day, 30 minutes before meals. The treatment course is 4 weeks.
Traditional Chinese Medicine group :Jibei Haiwa Decoction (composed of Bletilla striata 15g, Fritillaria thunbergii 10g, Sepia esculenta 10g, calcined Arca subcrenata 15g, and Amomum villosum 6g) was

Sponsors

Wangjing Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the Western medical diagnostic criteria for GERD and the traditional Chinese medicine diagnostic criteria. 2) Aged between 18 and 75 years old regardless of gender. 3) Have not taken any medications related to the treatment of this disease (such as PPI drugs) within at least one week prior to entering the study and are not participating in any other ongoing research. 4) Volunteer to participate in the study and sign the informed consent form personally. 5) Usually reside in the location where the treatment is provided which is conducive to treatment and follow - up.

Exclusion criteria

Exclusion criteria: (1) Have a history of digestive tract surgeries such as esophageal gastric or duodenal surgeries. (2) Have a history of tumors or organic diseases in the heart liver kidneys etc. or suffer from mental illnesses. (3) Be accompanied by severe organic digestive tract diseases such as digestive tract malignancies. (4) Be hypertensive patients who have been taking calcium - channel blocker drugs for a long time or be diabetic patients with poor blood - glucose control. (5) Suffer from primary diseases such as primary heart diseases or primary kidney diseases. (6) Have an allergic constitution or be allergic to the components of the drugs under study. (7) Be pregnant or lactating women or female patients with a recent fertility plan. (8) Have a history of alcoholism and drug abuse.

Design outcomes

Primary

MeasureTime frame
Gerd Q;

Secondary

MeasureTime frame
TCM Symptom Rating Scale;

Countries

China

Contacts

Public ContactTao Liu

Wangjing Hospital China Academy of Chinese Medical Sciences

ltlyf2@163.com13521218699

Outcome results

None listed

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