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Clinical Trials/CTRI/2025/07/090302
CTRI/2025/07/090302
Not yet recruiting
Phase 3 4

A clinical study to evaluate the therapeutic efficacy of panchtikta basti Followed by shamana chikitsa (palash arka) in the management of Madhumeha (diabetes mellitus)

PG Department of Panchkarma Post Graduate Institute of Ayurveda DSRRAU Jodhpur1 site in 1 country30 target enrollmentStarted: August 1, 2025Last updated:

Overview

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
PG Department of Panchkarma Post Graduate Institute of Ayurveda DSRRAU Jodhpur
Enrollment
30
Locations
1
Primary Endpoint
Improvement in classical signs and symptoms of Madhumeha

Overview

Brief Summary

This is a single arm open label prospective clinical trial to evaluate the therapeutic efficacy of Panchtikta Basti followed by Shamana Chikitsa with Palash Arka in the management of Madhumeha which correlates with Type 2 Diabetes Mellitus A total of 30 patients aged between 20 to 60 years having classical signs and symptoms of Madhumeha will be selected The study includes 15 days of Panchtikta Basti therapy in 3 cycles with Niruha and Anuvasana Basti followed by 45 days of oral administration of Palash Arka The effects will be assessed based on subjective symptoms and objective parameters like fasting and postprandial blood sugar and urine sugar levels

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients willing to give written consent Patients of non insulin dependent diabetes mellitus with fasting blood sugar between 126 to 300 mg per dl or post prandial blood sugar between 180 to 400 mg per dl Patients having classical signs and symptoms of Prameha according to Ayurveda and modern medicine.

Exclusion Criteria

  • Patients below 20 years and above 60 years of age Patients of Prameha with chronicity more than 20 years Patients of Type 1 diabetes or Type 2 diabetes who are taking insulin Patients having serious complications like diabetic nephropathy neuropathy retinopathy diabetic foot or carbuncles Patients with drug or chemically induced Type 2 diabetes such as from glucocorticoids or thyroid hormones Diabetes associated with carcinoma or other systemic illnesses Pregnant and lactating women Patients unfit for Basti Karma.

Outcomes

Primary Outcomes

Improvement in classical signs and symptoms of Madhumeha

Time Frame: Baseline 15th day 30th day and 60th day

Improvement in fasting and postprandial blood sugar levels

Time Frame: Baseline 15th day 30th day and 60th day

Improvement in urine sugar level

Time Frame: Baseline 15th day 30th day and 60th day

Secondary Outcomes

  • Assessment of general well being and quality of life after therapy(Baseline and 60th day)

Investigators

Sponsor
PG Department of Panchkarma Post Graduate Institute of Ayurveda DSRRAU Jodhpur
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Nihit Mathur

PG Department of Panchkarma Post Graduate Institute of Ayurveda

Study Sites (1)

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