A Clinical study on AMIRDHAVALLI CHOORANAM in the management of Madhumegam(Diabetes Mellitus)

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2021/02/031369
• Lead Sponsor: Government Siddha Medical College and Hospital

Brief Summary

The study is a prospective open labelled non randomized phase II clinical study on Amirdhavalli Chooranam in the management of Madhumega noi(Diabetes mellitus). The trial drug will be admistrated at the dose of 50mg/kg/BW/twice a dayA/F 45 days along with Hotwater as adjuvant in 60patients.The trial period of 12 months will be carrying out Government Siddha Medical College and Hospital,  Palayamkottai, Tirunelveli, Tamilnadu. The primary outcome will be evaluation of therapeutic efficacy of trial Drug AMIRDHAVALLI CHOORANAM. The secondary outcome will be the evaluation of siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of trial drug.Incase of any adverse event(AE) is noticed and it will be prefered to pharmacovigilance department of SCRI. Further management of the patient will be given in OPD facility.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-04
• Last Update Posted: 2021-05-02

Recruitment & Eligibility

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

Inclusion Criteria

Type II diabetes mellitus,previously diagnosed diabetic patients which are uncontrolled or poorly controlled for more than 2 years duration of the illness Even if the patient is having any one among the three: FBS-126mg/dl to 250mg/dl PPBS-200mg/dl to 350mg/dl HbA1C-6.5-10 Patients with symptom of polyuria, polydipsia,polyphagia,asthenia,nocturia,obesity,numbness,tingling sensation,mood changes and irritability.

Exclusion Criteria

Age below 35 yrs above 60 yrs Type I DM Gestational DM Diabetes insipidus Pregnancy/lactating mother Chronic kidney disease Chronic liver disease Ischemic heart disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To develop evidence support for the effect of AMIRDHAVALLI CHOORANAM in the management of Madhumega Noi(Diabetes Mellitus)	45 days

Secondary Outcome Measures

Name	Time	Method
To collect various siddha literatures and modern journals	To evaluate Physio chemical,Phyto chemical,Bio-chemical analysis

Trial Locations

Locations (1)

Government Siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

MNaga Lakshmi

Principal investigator

8489299310

nagalakshmimuthumalai@gmail.com