Randomised comparative clinical trial to evaluate the efficacy of Chandrakala gutika and Mamajjaka Ghanavati in the management of madhumeha with special reference to Diabetes Mellitus type II
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The primary outcome of the study will be the change in FBS/PPBS levels from baseline to the end of the treatment period.
Study Overview
Brief Summary
Diabetes mellitus (DM) is defined as a disturbance of intermediary metabolism, manifesting as a chronic sustained hyperglycemia primarily due to either an absolute or relative lack of insulin. It is a metabolic disorder characterized by polyuria, polydipsia, weight loss, fatigue etc., sometimes associated with complications of retina, kidney, and nervous system. India has already become the “ Diabetes Capital” of the world, with over 3 crore affected patients, which is a tip of iceberg. Despite the availability of conventional treatments like Metformin, achieving optimal glycemic control in T2DM remains a challenge for many patients. Additionally, concerns regarding side effects and long-term sustainability of pharmacological interventions signifies the need for exploring alternative therapies. Though there are so many ongoing and completed studies on efficacy of Ayurvedic management of DM, most of them shows is effective in reducing the subjective parameters and no much change is observed in FBS, PPBS and is recommended to carry out the study in a larger number of patients. Investigating the efficacy of Chandrakala gutika in comparison to Mamajjaka Ghanavati offers an opportunity to diversify treatment options and potentially improve outcomes. Therefore, keeping all these facts in mind, it has been decided to conduct a clinical study entitled as “RANDOMISED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF CHANDRAKALA GUTIKA AND MAMAJJAKA GHANAVATI IN THE MANAGEMENT OF MADHUMEHA WITH SPECIAL REFERENCE TO DIABETES MELLITUS TYPE II”
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient aged between 30 to 65 years
- •Patient having symptoms of Madhumeha
- •Patient with FBS in range of 126mg/dl to 250mg/dl and PPBS in range of 200mg/dl to 350 mg/dl or both and HbA1c less than 10%
- •Patient consuming oral-hypoglycemic agents for a duration more than 1 year and having poor glycemic control
- •Patient with chronicity less than 5 years
- •Patient with willingness to participate in the study and provide informed consent.
Exclusion Criteria
- •Pregnant and lactating women
- •Patient with type 1 diabetes
- •Patient with FBS more than 250mg/dl PPBS more than 350 mg/dl
- •Patients with Madhumeha upadrava or asadhya laxana
- •Patients with DM 2 on insulin therapy and Drug induced diabetes mellitus
- •Patients with hepatic impairment.
- •Uncontrolled hypertension.
Outcomes
Primary Outcomes
The primary outcome of the study will be the change in FBS/PPBS levels from baseline to the end of the treatment period.
Time Frame: Baseline to the end of the treatment period.
Secondary Outcomes
- Secondary outcomes will include changes subjective parameters, HbA1c, liver function tests, renal function tests, and incidence of adverse events(Baseline, 45th day ,end of the treatment period.)
Investigators
Chinmayi MK
National Institute of Ayurveda, Deemed to be university, Jaipur