| CTRI Number |
CTRI/2025/03/083301 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [curative] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to compare the effect of Ashok bark and Arjuna bark in the management of dushivishjanya vyang with special reference to melasma as local application. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to evaluate the efficacy of Ashoka tvak lepa and Arjuna tvak lepa in the management of Dushivishjanya Vyanga w.s.r Melasma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Mudhgil |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Kurukshetra |
| Address |
PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Sector-8 Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9896518951 |
| Fax |
|
| Email |
pirumudgil20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya Mudhgil |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Kurukshetra |
| Address |
PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Sector-8 Umri Road, Kurukshetra
HARYANA
136118
India |
| Phone |
9896518951 |
| Fax |
|
| Email |
pirumudgil20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya Mudhgil |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Kurukshetra |
| Address |
PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Sector-8 Umri Road, Kurukshetra
HARYANA
136118
India |
| Phone |
9896518951 |
| Fax |
|
| Email |
pirumudgil20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna AYUSH University, sector-8 Umri road, Kurukshetra, Haryana-136118 India |
|
|
Primary Sponsor
|
| Name |
Institue For Ayurved Studies and Research, Shri AYUSH University , Kurukshetra |
| Address |
Institue For Ayurved Studies and Research, Shri AYUSH University , sector-8 Umri road, Kurukshetra, Haryana-136118 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 Satbir Kumar Chawla |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
Room no 85, PG Department of Agadtantra, IAS&R,Faculty of Ayurved, Shri Krishna AYUSH University, sec 8, Umri road, Kurukshetra-136118
Kurukshetra
HARYANA |
9813348824
satbirchawla4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishna AYUSH University, Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of vyanga having history of use of cosmetics like moisturizer, fairness cream, topical steroid application etc upto 5 years.
Patients having habit of sleep during day time.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical assessment of Ashok tvak lepa and Arjuna tvak lepa in dushivishjanya vyanga with special reference to Melasma as local application. |
4 weeks and follow up on 5th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the changes in quality of life in patients.
|
2 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In Ayurveda, skin health reflects the status of rasa dhatu and rakta shatu. . A loss of snigdhata can lead to rukshata & kharata causing vata vridhi and increasing susceptibility to skin diseases like kushta. Many fairness creams contain topical steroids, which can lead to conditions collectively known as Topical Steroid Damaged Facies(TSDF) , understood in Ayurveda as dushivish janya vikara, affecting deeper tissues and causing disoders like Vyanga. Acharya Susruta has mentioned Rodhradi gana which includes varnya and vish nashak properties. Ashoka , which is among this gana is taken for bahirparimarjan chikitsa for dushivishjanya vyanga. |