An Open Randomized Comparative Clinical Study Of Pathadi Kashaya And Haridradi Kashaya In The Management Of Kaphaj Prameha With Special Reference To Type 2 Diabetes Mellitus

Seth RV Ayurved Hospital1 site in 1 country76 target enrollmentStarted: February 6, 2025Last updated: March 5, 2025

Trial Snapshot

Phase: Phase 3 4
Status: Not yet recruiting
Sponsor
Enrollment: 76
Locations: 1
Primary Endpoint: Prabhut Mutrata (Excessive Urination)

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This study is designed to evaluate and compare the clinical efficacy of two classical Ayurvedic formulations - Pathadi Kashaya and Haridradi Kashaya - in the management of Kaphaj Prameha with special reference to Type 2 Diabetes Mellitus. Kaphaj Prameha is a Kapha - Meda dominant disorder described in Ayurvedic texts, characterized by symptoms such as Prabhuta Mutrata (excessive urination), Avil Mutrata (turbid urination), Pipasa Adhikya (excessive thirst), Ati Kshuda (excessive appetite), Kara Pada Daha (burning sensation in the extremities) and Shithilangata (loss of muscle tone). It bears a strong clinical resemblance to T2DM, a lifestyle-related metabolic disorder marked by insulin resistance and persistent hyperglycemia. Given the rising prevalence of T2DM in India and limitations of conventional therapies—such as adverse effects and long-term dependency—there is a growing need for safer, multi-targeted alternatives. The selected formulations possess Kapha-Medohara and Agnideepana properties, potentially addressing the root pathology of both conditions. The primary objective of this open, randomized, comparative clinical trial is to assess whether these Kashayas, administered in a dose of 40 ml twice daily with 10 ml of honey as anupan before meals (Pragbhakta) for 60 days, can significantly reduce both clinical symptoms and biochemical markers. A total of 76 patients will be randomized into two groups. Subjective parameters assessed include classical signs of Kaphaj Prameha using a structured gradation scale, while objective parameters include fasting and postprandial blood sugar, urine sugar, body weight, BMI, abdominal and mid-arm circumference, and HbA1c (in a subset of patients). The study hypothesizes that both Pathadi and Haridradi Kashaya are effective in the management of Kaphaj Prameha, with potential for differential efficacy, and aims to contribute evidence supporting the role of Ayurvedic interventions in integrative diabetes care.

Study Design

Study Type: Interventional
Allocation: Random Number Table
Masking: Not Applicable

Eligibility Criteria

Ages: 20.00 Year(s) to 70.00 Year(s) (—)
Sex: All

Inclusion Criteria

•Patients between the age group of 20 years to 70 years. Sex All genders. Patients with classical signs and symptoms of Kaphaj Prameha Newly diagnosed cases of DM or known case of DM for less than 5 years. Subject who are willing to give written informed consent. BSL Fasting 126 mg per dl to 180 mg per dl And,or post prandial.
•140 mg per dl to 200 mg per dl.

Exclusion Criteria

•Patients on insulin therapy.
•Patient having any Diabetic complications or uncontrolled hyperglycaemia.
•Patients who are on Immunosuppressant medication.
•Pregnant women and lactating mother.
•Known cases of Diabetes Mellitus for more than 5 years.
•Patients with uncontrolled hypertension Patients with severe kidney or liver dysfunction.
•Patients with a history of significant cardiovascular events within the last 6 months.
•Patients who have undergone major surgery within the last 3 months.
•Patients with any active infections, especially those requiring systemic treatment.
•Patients with a history of substance abuse like alcohol, drugs within the past year.
•Patients with severe psychiatric conditions like schizophrenia, bipolar disorder that could impair their ability to comply with the study protocol.
•Patients with severe gastrointestinal conditions like inflammatory bowel disease, malabsorption syndromes that could affect the absorption of the study medications.