| CTRI Number |
CTRI/2025/04/085503 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of Dhatripayasyadi Ghrita in Karshya(underweight) |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO ASSESS THE EFFICACY OF DHATRIPAYASYADI GHRITA IN THE MANAGEMENT OF KARSHYA (UNDERWEIGHT) |
| 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 Sruthy Kurup |
| Designation |
PG Scholar |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF KAYACHIKITSA
ALVAS AYURVEDA MEDICAL COLLEGE
MOODUBIDIRE
DAKSHINA KANNADA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8590595985 |
| Fax |
|
| Email |
sruthykurupkmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Pai |
| Designation |
Professor |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF KAYACHIKITSA
ALVAS AYURVEDA MEDICAL COLLEGE
MOODUBIDIRE
DAKSHINA KANNADA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8921385332 |
| Fax |
|
| Email |
mdalvasayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sruthy Kurup |
| Designation |
PG Scholar |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF KAYACHIKITSA
ALVAS AYURVEDA MEDICAL COLLEGE
MOODUBIDIRE
DAKSHINA KANNADA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8590595985 |
| Fax |
|
| Email |
sruthykurupkmr@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
MOODUBIDIRE
DAKSHINA KANNADA
KARNATAKA |
|
|
Primary Sponsor
|
| Name |
Dr Sruthy Kurup |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
MOODUBIDIRE
DAKSHINA KANNADA
KARNATAKA
574227 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sruthy Kurup |
ALVAS AYURVEDA MEDICAL COLLEGE |
PG STUDIES IN THE DEPARTMENT OF KAYACHIKITSA
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
MOODUBIDIRE
DAKSHINA KANNADA
KARNATAKA
574227
Dakshina Kannada
KARNATAKA |
8590595985
sruthykurupkmr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee Alvas ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M95-M95||Other disorders of the musculoskeletal system and connective tissue. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatri Payasadi Ghrita, Reference: 10. Arogyaraksha Kalpadruma of Shri.Kaikulangara Rama warrier written by Dr.Lal Krishnan Second edition,published by Choukambha publications ,Varanasi 2012 Chapter number 28 shloka Number 40 page number 248., Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidaryadi Ghrita, Reference: 12. Ashtanga Hridaya Volume 2 of Acharya Vagbhata by Prof.Srikantha Murthy published by Krishnadas Academy Reprint edition 2015 Chikitsa sthana chapter no. 3 Shloka no.10 Page no.217., Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who fulfill the diagnostic criteria.
Patients who give written consent.
|
|
| ExclusionCriteria |
| Details |
Patient who suffer from karshyata due to vyadhi Upadravas like Grahani etc..
Patient with any other systemic disorders (like that of DM,Hypertension)
Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients who are having BMI less than 18.5 |
Baseline (0th day), 16th day, 31stday and 46th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2) Patients who are having two or more lakshanas of Karshya(which includes Shushka sphik udara greeva, dhamanijaala santatha, twak asthi shosha and sthoola parva) |
Baseline (0th day), 16th day, 31stday and 46th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2025 |
| 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="20" |
|
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
|
AIM OF STUDY
To
assess the Efficacy of Dhatri Payasyadi Ghrita in Management of Karshya.
OBJECTIVE OF STUDY
To assess the Efficacy of Dhatri Payasyadi Ghrita in Management of Karshya.
To Compare the Efficacy of Dhatri Payasyadi Ghrita with Vidaryadi
Ghrita in the Management of Karshya
HYPOTHESIS
H0- There is
neither statistical significant difference between the efficacy of Dhathripayasyadi ghrita and Vidaryadi ghrita nor Dhathripayasyadi ghrita is better than Vidaryadi ghrita in the management of Karshya
H1- There is statistical significant difference between the
efficacy of Dhathripayasyadi ghrita and Vidaryadi
ghrita with Dhathripayasyadi ghrita is having better effect than Vidaryadi
ghrita in the management of Karshya
|