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Safety and Effectiveness of Bhutanese Traditional Herbal Drug Formulary for Gastritis-related Problems

Safety and Effectiveness of Bhutanese Traditional Herbal Drug Formulary for Gastritis-Related Problems: A National Prospective Observational Study (SEDRU)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Observational
Source
TCTR
Registry ID
TCTR20180430004
Enrollment
1000
Registered
2018-04-30
Start date
2020-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Gastritis&#45

Interventions

Punica granatum L. + Cinnamomum zeylanicum Nees. + Piper pedicellatum C. DC. + Elettaria cardamomum Malton.,Punica granatum L. + Cinnamomum zeylanicum Nees. + Piper pedicellatum C. DC. + Elettaria car
Treatment,Treatment,Treatment,Treatment,Treatment,Treatment,Treatment
Sedru 4,Sedru 5,Sedru 8,Sedru Dangnay,Sedru Nyikhil,Ruta 6,Zhijay 6

Sponsors

Department of Traditional Medicine Services (DTMS), Bhutan
Lead Sponsor
Thai Traditional Medicine Research Institute (TTMRI)&#44
Collaborator
Thailand
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult age at least 18 years old Gastritis-equivalent problems (wind energy and phlegm disorders)

Exclusion criteria

Exclusion criteria: Severe GI problems Bile disorders མཁྲིས་ཤས་ཆེ་བའི་ནདཔ། Allergy to the components of the medicine Severe gastritis or peptic ulcer on upper gastrointestinal endoscopy

Design outcomes

Primary

MeasureTime frame
Safety / Adverse Drug Reaction (ADR) Week 1, 2, 3, 4 Naranjo's Algorithm

Secondary

MeasureTime frame
Gastritis Symptoms Week 0, 1, 2, 3, 4 Severity of Dyspepsia Assessment (SODA)

Countries

Bhutan

Contacts

Public ContactTHINLEY DORJI

Jigme Dorji Wangchuck National Referral Hospital, Thimphu, Bhutan

dorji.thinleydr@gmail.com+97517997979

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026