| CTRI Number |
CTRI/2025/05/087070 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Pathadi Kashaya and Haridradi Kashaya for Managing Type 2 Diabetes in 76 Patients |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemal Bharat Dhagai |
| Designation |
PG Scholar |
| Affiliation |
APMS Ayurved Mahavidyalaya, Sion |
| Address |
2A/17, Ambekar Nagar, 4th floor, Sanghamitra CHS, opposite Chunabhatti railway station, Chunabhatti, Sion east, Mumbai 22
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9867014440 |
| Fax |
|
| Email |
dhagaigauri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemal Bharat Dhagai |
| Designation |
PG Scholar |
| Affiliation |
APMS Ayurved Mahavidyalaya, Sion |
| Address |
2A/17, Ambekar Nagar, 4th floor, Sanghamitra CHS, opposite Chunabhatti railway station, Chunabhatti, Sion east, Mumbai 22
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9867014440 |
| Fax |
|
| Email |
dhagaigauri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anaya Ashish Pathrikar |
| Designation |
HOD and Professor |
| Affiliation |
APMS Ayurved Mahavidyalaya, Sion |
| Address |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth RV Ayurvedic College and Hospital, Near Sion Railway Station, Sion East, Mumbai 22, India |
|
|
Primary Sponsor
|
| Name |
Seth RV Ayurved Hospital |
| Address |
Near Sion Railway Station, Sion East, Mumbai 400022 |
| Type of Sponsor |
Other [Charitable Ayurvedic Hospital] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemal Bharat Dhagai |
Seth RV Ayurvedic College and Hospital |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA |
9867014440
dhagaigauri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMS Ayurved Mahavidyalaya, Sion |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: KAPAJAPRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridradi Kashaya, Reference: Harita Samhita Sthan 3 Adhyaya 28-40, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathadi Kashaya, Reference: Ashtang Sangraha Chikitsasthan 14-7, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prabhut Mutrata (Excessive Urination)
Avil Mutrata (Turbid Urination)
Pipasa Adhikya (Excessive Thirst)
Ati Kshudha (Excessive Appetite)
Kara-Pada Daha (Burning sensation of hands and feet)
Shithilangata (Loss of muscle tone)
Blood sugar level fasting
Blood sugar level post prandial |
baseline
day 15
day 30
day 45
day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |