Effect Of Herbo Mineral Compound In The Management Of Type 2 Diabetes Mellitus.

Phase 2

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2022/04/042289
• Lead Sponsor: MS Shree Dhootapapeshwar Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Confirmed diagnosis of Type II Diabetes Mellitus by HbA1c >=6.5% and <=8%.

2.Patients of either sex in the age group of 18-50years (Age >=18 and <= 50 years)

3.BMI up to 35.0 kg/m2

Women of child-bearing potential (Defined as all women physiologically capable of becoming pregnant, must use hormonal contraception) and Postmenopausal status / undergone tubal ligation / undergone hysterectomy.

Exclusion Criteria

1.Known hypersensitivity to Madhumeha Kusumakar Rasa or any of its components.

2.Evidence of pregnancy (Any one of Positive UPT, USG evidence produced by the patient or bearing a prescription with clinical diagnosis of pregnancy).

3.Participation in another trial or receipt of any investigational medicinal product within 90 days prior to Screening Visit.

4.History of episode of level 3 hypoglycemia or elicitable history of recurrent hypoglycemia as judged by the Investigator.

5.Type I Diabetes Mellitus or Secondary Diabetes.

6.History of acute metabolic complications of Diabetes within 3 months prior to Screening Visit.

7.History of any of the following in past 3 months: Episode of unstable angina, Acute Coronary Syndrome, or another significant cardiovascular event.

8.Uncontrolled treated or untreated hypertension.

9.Renal impairment (eGFR <60ml/min/1.73m2).

10.Hepatic impairment ( >3 times Upper limit of normal (UNL) of AST/ALT)

11.Known intake of opioids or abuse of alcohol or suspected abuse of alcohol.

12.History of chronic pancreatitis or idiopathic acute pancreatitis.

13.Any history of or diagnosis / treatment of any form of cancer within last 5 years.

14.Any history of severe neuropathy which prevents patient from complying with study procedures

15.Patient on medication that may promote hyperglycemia (e.g., Steroid)

16.Mental incapacity, which means those who cannot take decisions.

Patients treated with anti-obesity medications belonging to modern medicines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified