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

An Interventional, Single Centre, Open Label, Single Arm Trial To Study The Safety And Efficacy Of Madhumeha Kusumakar Rasa In Type 2 Diabetes Mellitus.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042289

Enrollment

Registered

2022-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of Type II Diabetes Mellitus by HbA1c >=6.5% and 2. Patients of either sex in the age group of 18-50years (Age >=18 and 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

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 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.

Design outcomes

Primary

Measure	Time frame
To study the efficacy of Madhumeha Kusumakar Rasa in reducing HbA1C in patients with Type II Diabetes Mellitus.Timepoint: 12-24 weeks	—

Secondary

Measure	Time frame
To study the effect Madhumeha Kusumakar Rasa on Insulin Sensitivity / HOMA-IR and Lipid Profile. To assess the safety of Madhumeha Kusumakar Rasa Timepoint: From Baseline to 12 to 24 weeks	—

Countries

India

Contacts

Public ContactDr Abhishek Upadhyay MD

National Institute of Ayurveda

harishbhakuni78@gmail.com7891233108

Outcome results