| CTRI Number |
CTRI/2025/07/090302 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Benefits of Ayurvedic Therapies (Panchtikta Basti and Palash Arka) in Managing Diabetes (Madhumeha) |
|
Scientific Title of Study
|
A clinical study to evaluate the therapeutic efficacy of panchtikta basti
Followed by shamana chikitsa (palash arka) in the management of
Madhumeha (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 |
Nihit Mathur |
| Designation |
PG Scholar |
| Affiliation |
PG Department of Panchkarma Post Graduate Institute of Ayurveda |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadwad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9799240782 |
| Fax |
|
| Email |
nihitmathur1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor Head of Department Panchkarma |
| Affiliation |
PG Department of Panchkarma Post Graduate Institute of Ayurveda |
| Address |
Room no. 11 PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadwad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor Head of Department Panchkarma |
| Affiliation |
PG Department of Panchkarma Post Graduate Institute of Ayurveda |
| Address |
Room no. 11 PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadwad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
PG Department of Panchkarma Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda DSRRAU Jodhpur 342037 Rajsthan India |
| Type of Sponsor |
Government medical college |
|
|
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 Nihit Mathur |
Post Graduate Institute of Ayurved Dr sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadwad Jodhpur
Jodhpur
RAJASTHAN |
09799240782
nihitmathur1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: charak samhita, Procedure details: Panchtikta Basti given for 15 days in 3 cycles followed by Palash Arka orally for 45 days Niruha Basti 500 ml daily for 4 days Anuvasana Basti 60 ml on every 5th day Palash Arka 24 ml twice daily before meals
)
(1) Medicine Name: Palash Arka, Reference: kalpit yoga, Route: Oral, Dosage Form: Arka, Dose: 24(ml), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in classical signs and symptoms of Madhumeha
Improvement in fasting and postprandial blood sugar levels
Improvement in urine sugar level |
Baseline 15th day 30th day and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of general well being and quality of life after therapy |
Baseline and 60th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 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 |