A clinical trial to study the effect of novel ayurvedic choorna in patients with Type 2 Diabetes mellitus

Phase 2

Not yet recruiting

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

• Registration Number: CTRI/2020/10/028201
• Lead Sponsor: Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka

Brief Summary

This study is randomized, open, parallel group, single centred trial comparing the safety and efficacy of Novel Ayurvedic choorna 12 gm daily in study group comparing with Nishamalaki choorna 12 gm daily in positive control group for 3 months in 20 each patients with Type 2 Diabetes Mellitus,  that will be conducted in Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka. The primary outcome measures will be estimation of Fasting Glucose Level, Two-hour plasma Glucose level and HbA1c. The secondary outcome measures will be clinical symptoms of Diabetes Mellitus (Pratyatmaka lakshanas of Prameha) and WHO Qualitry of life assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-10
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subjects of all gender and age group between 30-60 years will be included.
• Subjects with FBS greater than or equal to 126mg/dl and or PPBS greater than or equal to 200mg/dl will be included.
• Subjects with HbA1c greater than or equal to 6.5% Diagnosed cases of Type2 Diabetes Mellitus.
• Subjects with and without signs and symptoms of Prameha vis-a-vis Type2 Diabetes Mellitus will be included.

Exclusion Criteria

• Subjects with history of Diabetes Mellitus associated with complications like diabetic nephropathy, retinopathy, neuropathy, infectious wounds and gangrene will be excluded.
• Patients with known systemic disorders like; cardiac illness, renal pathologies, other endocrinal diseases, uncontrolled hypertension, infectious conditions and debilitating illness which interfere with intervention will be excluded.
• Patients of Type 2 Diabetes Mellitus who are on OHA and Insulin treatment will be excluded.
• Subjects on any other medications, drug and alcohol abuse, Steroids and Estrogen replacement therapy will be excluded.
• Pregnant and the lactating women will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose Level	3 month
Two-hour Plasma Glucose Level	3 month
HbA1c	3 month

Secondary Outcome Measures

Name	Time	Method
Clinical symptoms of Diabetes Mellitus.	WHO-QOL.

Trial Locations

Locations (1)

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan; 🇮🇳 Hassan, KARNATAKA, India

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan

🇮🇳Hassan, KARNATAKA, India

Dr Prasanna Narasimha Rao

Principal investigator

9448064277

profpnrao@gmail.com