| CTRI Number |
CTRI/2025/09/094444 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate the efficacy of Arjuna Twaka Lepa in Vyanga. |
|
Scientific Title of Study
|
Analytical and Clinical Study of Arjuna Twaka Lepa in Vyanga |
| 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 DC Singh Chauhan |
| Designation |
Campus Director and Head of Department |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
P.G. Department of Dravyaguna, Rishikul Campus,Haridwar Uttrakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411175362 |
| Fax |
|
| Email |
drdcschauhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DC Singh Chauhan |
| Designation |
Campus Director and Head of Department |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
P.G. Department of Dravyaguna, Rishikul Campus,Haridwar Uttrakhand
UTTARANCHAL
249401
India |
| Phone |
9411175362 |
| Fax |
|
| Email |
drdcschauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayushi Uniyal |
| Designation |
Post Graduation Scholar |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
P.G. Department of Dravyaguna, Rishikul Campus,Haridwar Uttrakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9520793882 |
| Fax |
|
| Email |
ayu101097@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus Uttrakhand Ayurveda University Uttrakhand India Pin 249404 |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Haridwar |
| Address |
OPD no 1 Rishikul Campus Haridwar Uttrakhand Ayurveda University |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| AYUSHI UNIYAL |
RISHIKUL CAMPUS UTTRAKHAND AYURVEDA UNIVERSITY |
OPD NO. 1 ,PG DEPARTMENT OF KAYACHIKITSA
Hardwar
UTTARANCHAL |
9520793882
ayu101097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
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 | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kumkumadi Oil, Reference: Bhaisajya ratnavali Kshudra roga Adhikara Chapter 60 sloke no. 115-120, Route: Topical, Dosage Form: Taila, Dose: 4(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjuna twaka Lepa, Reference: Ashtang hridaya uttara tantra chapter 32 shloke no.16, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -Arjuna twaka lepa will be prepared with navneeta. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical sign and Symptoms of Vyanga (Melasma).
Patients will be selected between the age ground of 20-50 years.
Patients will be selected irrespective of gender and religion.
Patients willingly participating in study trial.
Chronicity less than 5 years. |
|
| ExclusionCriteria |
| Details |
1 Patients of age below 20 years and above 50 years.
2 Patients having secondary systemic illness.
3 Melasma due to Tubercular therapy or malignant cases.
4 Any kind of heriditary skin disorder like Nevi ,freckles etc.,
5 Patients taking OCP’s, pregnant women,lactating mothers. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in size and no. of lesion,decrease in darkness of pigmentation, |
The assessment will be done 3 times at an interval of 15 days till 45 days during the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in hyperpigmentation lesions (Mandala) |
The assessment will be done 3 times at an interval of 15 days till 45 days during the |
|
|
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 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| 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="8"
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
|
This study is a Randomised controlled clinical trial to determine the efficacy of Arjuna Twaka Lepa in Vyanga (Melasma).Melasma is a melanogenesis condition that causes hyperpigmentation and is characterized by
symmetrical brown to gray-black macules and patches with serrated uneven borders.In Ayurveda it can be co-related to Vyanga. A total no. of 40 patients will be taken between the age group of 20 to 50 years for 45 days. Study will be conducted at OPD level in PG department of Kayachikitsa. Assessment will be done on the basis of subjective and objectives parameters. Study will be clinical trial and result obtained will be tabulated and statistically analyzed using appropriate tests.The Aim is to Provide a safe and effective Ayurveda Treatment for Melasma with lesser side effects.
|