| CTRI Number |
CTRI/2025/04/085559 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Chaarmrog Chikitsa |
|
Scientific Title of Study
|
A Comparative Clinical Study On Efficacy Of Dushivishari Agad Ghan Vati And Chandraskaladi Vatak In Dushivishjanya Kotha With Special Refference To Urticaria |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Mehta |
| Designation |
MD scholar |
| Affiliation |
PG Department of Agad Tantra National Institute Of Ayurveda Deemed To Be University ( De- novo ) Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India |
| Address |
PG Department of Agad Tantra National Institute Of Ayurveda Deemed To Be University ( De- novo ) Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9610031350 |
| Fax |
|
| Email |
jyotimehta871@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anita Sharma |
| Designation |
Professor and HOD of Agad Tantra Department |
| Affiliation |
PG Department of Agad Tantra National Institute Of Ayurveda Deemed To Be University ( De- novo ) Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India |
| Address |
PG Department of Agad Tantra National Institute Of Ayurveda Deemed To Be University ( De- novo ) Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Mehta |
| Designation |
MD scholar |
| Affiliation |
PG Department of Agad Tantra National Institute Of Ayurveda Deemed To Be University ( De- novo ) Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India |
| Address |
PG Department of Agad Tantra National Institute Of Ayurveda Deemed To Be University ( De- novo ) Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9610031350 |
| Fax |
|
| Email |
jyotimehta871@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
PG Department of Agad Tantra National Institute Of Ayurveda Deemed To Be University ( De- novo ) Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 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 Jyoti Mehta |
National Institute of Ayurveda |
PG Department of Agad Tantra National Institute Of Ayurveda Deemed To Be University ( De- novo ) Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN |
9610031350
jyotimehta871@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurveda Deemed To Be University Amer Road Jaipur Rajasthan India 302002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L500||Allergic urticaria. Ayurveda Condition: KOTHAH, (2) ICD-10 Condition:L500||Allergic urticaria. Ayurveda Condition: KOTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chandraskaladi Vatak , Reference: A.H.CHI. 19/ 44, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Normal Water ), Additional Information: No | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dushivishari Agad Ghan Vati, Reference: Su. Kalp. 2/ 50-52, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Madhu ), Additional Information: No |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group 18-60 years of age
Patients of either gender.
The patients having classical signs and symptoms of kotha.
1. Mandalotpatti
2. Kandu
3. rag
Patients willing to participate in the clinical trial.
Patients will be assed on the basis of urticaria activity score(0 -4).
|
|
| ExclusionCriteria |
| Details |
Patient with long term history of steroid and cytotoxic treatment
Pregnant and lactating women
Patients having illness like Hypertension, Diabetes mellitus, HIV, Malignancy, etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in score of Urticaria control scale clinical improvement in sign, symptoms of dushivisha janya kotha |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in CBC ESR AEC |
21 days |
|
|
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)
|
01/06/2025 |
| 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
|
Ayurvedic Literature has vast references of Formulations indicated for Clinical Conditions Similar to urticaria. Dushivishari Agad is referenced drug from Shushrut
Samhita Kalpstana which work on Dushivishjanya
Vikar. Chandraskaladi Vataka is
a referenced drug from Astang hridya kushta chikitsa which
used in samastha kushta nasa . In Astang
Hridya, chakradatt and yogratnakar samhita kotha chikitsa similer like kushta chikitsa.. |