A clinical study on obese diabetics to evaluate the role of Ayurvedic formulation in the Management of Sthula Prameha.

A Randomized Placebo Controlled Clinical Study to Evaluate the Role of Prameha Vijay Vati in the Management of Sthula Pramehi. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092360

Enrollment

140

Registered

2025-08-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Patients willing for trial and ready to give written consent. Patients of either sex with age between 35 to 70 years. Obese patients i.e., weight is more than 20 percent excess of the desirable weight according to height, sex and age (according to annexed height and body weight table) Or Age adjusted BMI above 85th percentile (Indian standard). Newly diagnosed drug naive patients of Type 2 Diabetes being having Glycosylated Haemoglobin (HbA1c) between 7 to 9 percent or known cases of Type 2 Diabetes with HbA1c 7 percent to 9 percent with maximum dose of metformin up-to 2.5gm per day

Exclusion criteria

Exclusion criteria: Patients not willing for the trial. Poorly controlled hypertensive patients (SBP greater than or equal to 160mm of Hg and or DBP greater or equal to 100mm of Hg). Patients with FBS greater than 300 mg per dl; RBS greater than 400 mg per dl; HbA1c greater than 9 percent. Patients having concomitant disorders like ischemic heart disease, congestive heart failure, established coronary artery disease and any other clinically significant cardiovascular disease. Patient suffering from renal and hepatic dysfunction. Patients suffering from major systemic illness necessitating long term treatment or long term steroids (R.A., PTB, S.L.E, malignancy). Lactating and Pregnant women.

Design outcomes

Primary

Measure	Time frame
To evaluate the role of Prameha Vijay Vati in the management of Prameha associated with Sthaulya.Timepoint: Twelve weeks	—

Secondary

Measure	Time frame
To evaluate the effect of drug on Medo Dhatu of Sthula Pramehi. To evaluate the safety of Prameha Vijay Vati.Timepoint: Twelve weeks	—

Countries

India

Contacts

Public ContactDr Priyanka Bhardwaj

Guru ravidas ayurveda university hoshiarpur punjab

vaidyaras03@gmail.com9814779242

Outcome results