| CTRI Number |
CTRI/2025/05/086942 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Pharmaceutical Analytical and Exploratory Study of Salsaradi Gana Processed with Shilajatu in the Treatment of Madhumeha
|
|
Scientific Title of Study
|
A Pharmaceutico-Analytical And Exploratory Study Of Salsaradi
Gana Bhawit Shilajatu In The Management Of Madhumeha
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahaveer singh ashiya |
| Designation |
MD scholar |
| Affiliation |
PGIA Jodhpur |
| Address |
C/O Kishan singh,92,Rawali pol,Bijliyawas,post khariya soda,teh sojat city,distt pali ,Rajasthan
Rasashastra and Bhaishajya Kalpana PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037
Jodhpur
RAJASTHAN
306001
India |
| Phone |
7023232889 |
| Fax |
|
| Email |
mahaveersingh.ashiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrabhan sharma |
| Designation |
Assistant Professor |
| Affiliation |
PGIA Jodhpur |
| Address |
Rasashastra and Bhaishajya Kalpana PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
PGIA Dr S R Rajasthan Ayurved University Jodhpur distt jodhpur Rajasthan
342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9571779217 |
| Fax |
|
| Email |
drcbsharma42@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahaveer singh ashiya |
| Designation |
MD scholar |
| Affiliation |
PGIA Jodhpur |
| Address |
Rasashastra and Bhaishajya Kalpana PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7023232889 |
| Fax |
|
| Email |
mahaveersingh.ashiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIA Dr S R Rajasthan Ayurved University Karwar Nagaur road Jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur Rajasthan |
| Address |
PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mahaveer singh ashiya |
RS&BK Department PGIA Karwar Jodhpur Rajasthan 342304 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahaveer singh ashiya |
Sanjeevani Hospital |
Room No. 10 PGIA Dr
S R Rajasthan Ayurved
University Jodhpur
Jodhpur
RAJASTHAN |
07023232889
mahaveersingh.ashiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Salsaradi Gana Bhawit Shilajatu , Reference: Rasataranginii, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Salsaradi Gana kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving the clinical history of Madhumeha
Presence of cardinal symptoms of diabetes mellitus eg 3P Polyuria Polydipsia
Polyphagia
Patient fasting blood sugar level is 126mg per dl to 200mg per dl and Post Prandial
Blood Sugar PPBS level is 200mg per dl to 350mg per dl
The fresh diagnosed case of type II DM will include |
|
| ExclusionCriteria |
| Details |
Patients below 30 year and above 65 years will be excluded
Pregnant women or the women planning to be pregnant in next 6 month
lactating mother
CVS disorder CAD
CNS disorder eg encephalopathy
Patient of type II DM who are on insulin therapy
Patient of type I DM |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change In Subjective And Objective Parameter |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of life of Patient |
90 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="0"
Months="3"
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
|
Ayurveda, an ancient system of health care, is based on the knowledge of the Vedas and uses herbal, mineral/metal, and animal substances for therapeutic purposes. A key aspect of Ayurveda, Rasa Shastra, focuses on herbo-mineral formulations (Rasaushadhies), which are known for their faster effects and longer shelf life due to their fine-particle size, allowing them to target specific cells. Shilajatu, a significant herbo-mineral medication, is highly valued in Ayurveda for its rejuvenating properties, which help delay aging and promote strength. It is noted for its various beneficial components like rasa, uparasa, parada, ratna, and lauha. The study explores Shilajatu purified with Triphala kwatha and combined with Salsaradi Gana dravya to treat Madhumeha (diabetes mellitus), a metabolic disorder caused by insulin deficiency, leading to symptoms like high blood sugar and frequent urination. Ayurveda offers alternative therapies to manage Madhumeha, and Salsaradi Gana Bhawit Shilajatu enhances Shilajatu’s potency, offering a promising treatment option for the condition. |