| CTRI Number |
CTRI/2025/02/080134 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study of Triushnadi Vati and Salsaradi Prameh Nashak Yoga in the Ayurvedic Management of Diabetes Mellitus |
|
Scientific Title of Study
|
A Comparative Study of Triushnadi Vati and Salsaradi Prameh Nashak Yoga in the Management of Madhumeha roga w.s.r. to 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 |
Dr Shivangi Rathor |
| Designation |
PG scholar Department of Kayachikitsa |
| Affiliation |
Govt Auto Dhanwantari Ayurveda Medical College Mangalnath Marg Ujjain MP |
| Address |
Room No. 18 Kayachikitsa Department Govt. Dhanwantari Ayurved Hospital Ujjain
Nil
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
8103155794 |
| Fax |
|
| Email |
rathoreshivangi54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr O P Vyas |
| Designation |
Professor Department of Kayachikitsa |
| Affiliation |
Govt Auto Dhanwantari Ayurveda Medical College Mangalnath Marg Ujjain MP |
| Address |
Room No. 18 Kayachikitsa Department Govt. Dhanwantari Ayurved Hospital Ujjain
Nil
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
9713574071 |
| Fax |
|
| Email |
opvyas24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivangi Rathor |
| Designation |
PG Scholar |
| Affiliation |
Govt Auto Dhanwantari Ayurveda Medical College Mangalnath Marg Ujjain MP |
| Address |
Room No. 18 Kayachikitsa Department
Nil
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
8103155794 |
| Fax |
|
| Email |
rathoreshivangi54@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt dhanwantari ayurveda hospital ujjain ( M.P.) INDIA pin- 456010 |
|
|
Primary Sponsor
|
| Name |
Govt Auto Dhanwantari Ayurveda Medical College Ujjain MP INDIA |
| Address |
Mangalnath Marg Ujjain MP INDIA pin- 456006 |
| 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 Shivangi Rathor |
Govt Auto Dhanwantari Ayurveda Hospital Ujjain M.P. Pin- 456010 |
Kayachikista department OPD no 18
Ujjain
MADHYA PRADESH |
8103155794
rathoreshivangi54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee govt auto dhanwantari ayurveda medical College and hospital ujjain |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Triushnadi vati , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: qid, Bhaishajya Kal: Samudga, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: -(2) Medicine Name: Salsaradi prameh nashak yoga , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Samudga, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical signs and symptoms of Madhumeha as mentioned below-
Prabhut Avilmutrata, Kara pada daha, Kara pada suptata, Madhuryam aasyata, Gala talu shosh, Shithil angata, Nidra adhikya, Kshudra adhikya, Trushna adhikya, Ati swed, Visrasharirgandha, shrama swas, Ghana angata, Kesh nakhativridhi, Dantadhinam maladhayatam, Panipadyo Dahashch Chikkanata Dehe. |
|
| ExclusionCriteria |
| Details |
Diabetic patient having major complication like Neuropathy, Cardiomyopathy,
Carbuncles, Diabetic retinopathy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the intensity of classical signs and symptoms of Madhumeha like Prabhut Avilmutrata, Kara pada daha, Kara pada suptata, Madhuryam aasyata, Gala talu shosh, Shithil angata, Nidra adhikya, Kshudra adhikya, Trushna adhikya, Ati swed, Visrasharirgandha, shrama swasa |
After 8 Weeks of Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effective management of Madhumeha by relieving the clinical sign and symptoms of Prabhut Avilmutrata, Kara pada daha, Kara pada suptata, Madhuryam aasyata, Gala talu shosh, Shithil angata, Nidra adhikya, Kshudra adhikya, Trushna adhikya, Ati swed, Visrasharirgandha, shrama swasa |
After 2 month of study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/02/2025 |
| 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="0"
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
|
There is randomised interventional study of Triushnadi vati and Salsaradi prameh nashak yoga in the management of Madhumeha roga w.s.r. to Diabetes Mellitus. Total 60 patients will be enrolled in present study. Selected patient will be divided into 3 groups. Group A containing 20 patients of Madhumeha will be treated by Triushnadi vati. Group B containing 20 patients of Madhumeha will be treated by Salsaradi prameh nashak yoga and Group C containing 20 patients of Madhumeha will be treated with both Triushnadi vati and Salsaradi prameh nashak yoga for 60 days. |