To evaluate the Safety and efficacy of Unani formulations in the treatment of Hyperacidity
- Conditions
- Acute gastritis, hyperacidity,
- Registration Number
- CTRI/2013/10/004116
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM New Delhi
- Brief Summary
This study is designed as a multicentric open trial in patients with ***Kasrat- e- Ratubat-e-Hamoozi* (hyperacidity).** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on each fortnightly follow up. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 06 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 300
•Subjects in the Age group of 18-60 years •Subjects of both sexes •Subjects presenting with the following symptoms : oRetrosternal burning oEpigastric pain with retrosternal heaviness oAcidic brash oAnorexia oNausea oVomiting oPain relieved after vomiting.
- •Duodenal ulcer •Peptic ulcer •H/o previous gastric surgery •Presence of cardiac & lung diseases •Pregnancy/lactation •Alcoholism •Diabetes •Stomach carcinoma •Crohn’s Diseases •Allergy/Intolerance to any ingredients of the drug1,9,12.
- •Zollinger Ellison Syndrome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in signs and symptoms 6 WEEKS
- Secondary Outcome Measures
Name Time Method Outcome TimePoints Hematological and biochemical assessments for safety
Trial Locations
- Locations (3)
Regional Research Institute of Unani Medicine (RRIUM), Patna
🇮🇳Patna, BIHAR, India
Regional Research Institute of Unani Medicine, Aligarh
🇮🇳Aligarh, UTTAR PRADESH, India
Regional Research Institute of Unani Medicine, Srinagar
🇮🇳JAMMU, & KASHMIR, India
Regional Research Institute of Unani Medicine (RRIUM), Patna🇮🇳Patna, BIHAR, IndiaDR S MANZAR AHSANPrincipal investigator06122631106manzarahsan9@gmail.com