A clinical study to know efficacy of formulations, Saptachakra churna and Amalaki churna in Madhumeha management w.s.r Type-2 DM

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: Madhumeha, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

• Registration Number: CTRI/2022/07/043661
• Lead Sponsor: Dr Javeed Chougala

Brief Summary

This study is a randomised, single blind, parallel group, actively controlled clinical study with comparative standard drug - Amalaki Churna and  Trial drug - Saptachakra Churna with the dosage 5gm churna with ushnodaka before food BID. This study is conducting in Madhumeha patients belongs to age group between 20yrs - 70yrs who gives written and verbal consent for undergoing clinical study. Study will be conducting  in Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri. Intervention of the study is 30 days with day zero, day 11, day 21 and day 31 assessment.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-07
• Study Start: 2022-04-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Patients with FBS range Between 126.
• 250 mg/dL and PPBS range between 200.
• 350 mg/dL Type-2 Diabetes Mellitus will be selected for the study.

Exclusion Criteria

• Patients with High blood glucose levels FBS > 250mg/dL and PPBS > 350 mg/dL 2.
• Patients with complications like DKA, HHS, Diabetic Gangrene and Carbuncles 3.
• Gestational Diabetes, Patients on Insulin Type 2 Diabetes Mellitus.
• Diabetes with other Endocrine Disorders are excluded from the study 5.
• Patients suffering from other Systemic Diseases which may interfere with study will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of the treatment will be done based on detailed case proforma with objective parameters FBS and PPBS	30 days

Secondary Outcome Measures

Name	Time	Method
Effect of the treatment will be done based on detailed case proforma with subjective parameters such Prabhuta avila mutra, Ati Kshudha, Ati Trusha, Ati Sveda	30 days

Trial Locations

Locations (1)

Alvas Ayurveda Hospital; 🇮🇳 Kannada, KARNATAKA, India

Alvas Ayurveda Hospital

🇮🇳Kannada, KARNATAKA, India

Dr Javeed Chougala

Principal investigator

8951885120

javeedchougala@gmail.com