Effect of Rasayana Churna along with Metformin in Diabetes Mellitus II

Phase 2/3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,

• Registration Number: CTRI/2025/04/085987
• Lead Sponsor: Dr Saif Amir Chidre

Brief Summary

Diabetes Mellitus type II is a Metabolic disorder, characterized by impaired insulin secretion, insulin resistance, excessive hepatic glucose production, abnormal carbohydrate, protein and fat metabolism and systemic low-grade inflammation . This metabolic disorder results in long-term disease specific microangiopathy (nephropathy, retinopathy, neuropathy) and aggravation of macroangiopathy like Myocardial Infarction, Stroke. Diabetes can be correlated to Prameha in Ayurveda. Symptoms of Prameha like prabhut mutrata, avil mutrata, pipasaaadhikya can be correlated with polyuria, urine turbidity, polydipsia in Diabetes Mellitus type II.

Now a days, due to Urbanization, sedentary life style, increased population and improper dietary habits the prevalence of Diabetes is increasing, also diabetes results in complications, and significant economic burden. There is need for effective, safe, potent, drug which controls hyperglycemia and adverse reaction and limit the signs symptoms related to Diabetes Mellitus type II and enhance patient quality of life. Hence, the present study will be done on the effects of Rasayana Churna

Study Time-60 days

Follow up - 0,15,30,45,60

Total duration of study -18 Months

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-29
• Study Start: 2025-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 1. Patients aged between 25-70 years with irrespective of gender, education, religion, socio economic class.
• 2. Patients presenting with classical features of Prameha, that is pipasavridhi (Polydyspsia) , Prabhuta- mutrata (Polyuria), Avila -mutrata (Turbidity),Nakta-mutrata (Nocturia),Daurbalya(Fatigue).
• 3. Patients having sign and symptoms of Prameha 4) History of Diabetes Mellitus II Since 3 years and newly diagnosed cases.
• 5. Blood Sugar levels- Fasting more than 126 mg/dl PP more than 200 mg/dl 6) HbA1c more than 6.5% to 8%.

Exclusion Criteria

• 1. Patients with Insulin Dependent Diabetes Mellitus (DM I).
• 2. Patient with Diabetes mellitus II on Insulin therapy 3) History of Diabetes Mellitus-II more than 3 years 4) Patients aged less than 25 years and more than 70 years.
• 5. Patient presenting with Prameha due to the complication of other major systemic diseases like Heart diseases ,Diabetic Macrovascular and Microvascular complications, etc.
• 6. Pregnant women and lactating mothers will be excluded.
• 7. BSL- Fasting more than 250mg/dl ,PP more than 350mg/dl 8) HbA1c more than 8%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rasayana Churna is effective along with Metformin in Diabetes Mellitus II	60 Days

Secondary Outcome Measures

Name	Time	Method
Decrease HbA1C Level & Symptomes after 60 Days	60 Days

Trial Locations

Locations (1)

Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta; 🇮🇳 Sangli, MAHARASHTRA, India

Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta

🇮🇳Sangli, MAHARASHTRA, India

Dr Saif Amir Chidre

Principal investigator

9834640122

saifchidre453@gmail.com