CTRI/2024/10/074698
Not yet recruiting
Phase 2/3
An etiopathological study of madhumeha w.s.r. to diabetes mellitus type 2 and evaluation of comparative therapeutical effect of TRIPHALA-NIMBADI Churna(KALPIT) and NISHAMALAKI Churna.
Madan Mohan Malviya Govt Ayurved College Udaipur1 site in 1 country40 target enrollmentStarted: December 16, 2024Last updated:
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Madan Mohan Malviya Govt Ayurved College Udaipur
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. Improvement in signs and symptoms of Madhumeha(Diabetes Mellitus)
Overview
Brief Summary
This is a clinical trial to evaluate the comparative therapeutical effect of TRIPHALA-NIMBADI Churna (KALPIT) and NISHAMALAKI Churna in madhumeha (Diabetes mellitus type 2).In this study 20 patient will be administered with TRIPHALA-NIMBADI Churna and other 20 patients will be administered with NISHAMALAKI Churna.Dose of both drug will be 3gm twice a day with lukewarm water after meal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patient having clinical signs and symtoms of diabetes mellitus type
- •2.Patient having fasting blood sugar level between 126-300 mg/dl and post prandial blood sugar level 200-400 mg/dl.
Exclusion Criteria
- •1.Patient of type 1 diabetes.
- •2.Patient with gestational and drug induced diabetes mellitus.
Outcomes
Primary Outcomes
1. Improvement in signs and symptoms of Madhumeha(Diabetes Mellitus)
Time Frame: 60 days
2. Lower down of blood sugar level to healthy range.
Time Frame: 60 days
Secondary Outcomes
- 1. Improvement in signs and symptoms of Madhumeha(Diabetes Mellitus)(2. Lower down of blood sugar level to healthy range.)
Investigators
Dr Gopal Singh Bithu
Madan Mohan Malviya Govt Ayurved College
Study Sites (1)
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