With particular reference to Type 2 Diabetes Mellitus with poor glycemic Control a single arm clinical trial will assess the effectiveness of pramehagajakesari rasa and nyagrodhadi churna in combination with oral hypoglycemic agents.

A single arm clinical trial to study the efficacy of pramehagajakesari rasa and nyagrodhadi churna in integration with oral hypoglycaemic drugs with special reference to diabetes mellitus with poor glycaemic control. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084787

Enrollment

Registered

2025-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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. Type 2 diabetes mellitus patients with poorly controlled blood glucose with undergoing conventional treatment and hba1c 7.5% less than equal to 11%. 2. The patient has been taking oral hypoglycaemic agents for last 6 months or longer and has not changed in the past month.

Exclusion criteria

Exclusion criteria: 1. Patients with morbid illnesses like cva,renal failure uncontrolled hypertension etc. 2. Patients with insulin therapy,type 1 diabetes,special types of diabetes, or gestational diabetes. 3. History of diabetes secondary to pancratitis or pancreatectomy. 4. Ketoacidosis or lactoacidosis within 6 mpnths prior to screening. 5. Pregnant and lactating mothers.

Design outcomes

Primary

Measure	Time frame
Glycaemic control - change in glycosylated haemoglobin (hba1c) in sample size group of 30 patientsTimepoint: Glycaemic control - change in glycosylated haemoglobin (hba1c) within 12 weeks	—

Secondary

Measure	Time frame
1. Change in fasting plasma glucose(fpg) 2. Change in madhumeha(type 2 diabetes mellitus)lakshana(symptoms) 3. QOL: Audit of diabetes dependent quality of life(addqol-19)Timepoint: 1. Efficacy in fasting plasma glucose(fpg) within 90 days. 2. Efficacy in madhumeha(type 2 diabetes mellitus)lakshana(symptoms)within 90 days. 3. Efficacy in quality of life.	—

Countries

India

Contacts

Public ContactProf HML Meena

National Institute of ayurveda

hari_mohan68@yahoo.co.in9461297017

Outcome results