| CTRI Number |
CTRI/2022/06/042971 [Registered on: 02/06/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of Arjunadi lepa and Naturopathy based face mud pack in vyanga. |
|
Scientific Title of Study
|
A randomized clinical trial to evaluate the effectiveness of Arjunadi lepa and Naturopathy based face mud pack in vyanga with special reference to melasma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suman Bhamu |
| Designation |
PG scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of swasthvritta and Yoga
National institute of Ayurveda, jorawar sing gate, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413234905 |
| Fax |
|
| Email |
drsumanbhamu333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Kumar |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of swasthvritta and Yoga
National institute of Ayurveda, jorawar sing gate
Jaipur
RAJASTHAN
302002
India |
| Phone |
9555554077 |
| Fax |
|
| Email |
drravikumar786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Kumar |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of swasthvritta and Yoga
National institute of Ayurveda, jorawar sing gate
Jaipur
RAJASTHAN
302002
India |
| Phone |
9555554077 |
| Fax |
|
| Email |
drravikumar786@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas palace, Amer Road, Jaipur, Rajasthan, India 302002 |
| 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 Suman Bhamu |
National Institute of Ayurveda |
OPD, Department of Swasthavritta and Yoga, Madhav Vilas Palace, Amer road
Jaipur
RAJASTHAN |
9413234905
drsumanbhamu333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjunadi Lepa, Reference: Sarangdhar Samhita, Uttarkhanda, chapter11, shlok 12, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 15(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: 15-20 g of powder is mixed with butter to make a paste. The paste is then applied on affected area and left to dry. It is removed after approx. 30 minutes. | | 2 | Comparator Arm (Non Ayurveda) | | - | Yellow mud pack | Yellow Mud is mixed with clean water to prepare a paste. It is then applied on the affected area and left to dry. It is removed after approx. 30 minutes.
Frequency - bd
Duration - 8 weeks |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from classical clinical signs and symptoms of Vyanga
2. Patient of age 20 to 40 years irrespective of sex and religion |
|
| ExclusionCriteria |
| Details |
1.Patients receiving hormone or corticosteroid therapy
2.Patients with history of endocrine disorders or allergies.
3.Patients taking depigmenting or whitening products (oral or topical) within the previous 6 weeks.
4.Pregnant or breast feeding mother
5.Subjects who are allergic to chemical compound in the Lepa or fragrance.
6.Using a medication that increases sensitivity to sunlight including doxycycline, minocycline, tetracycline, ciprofloxin, hydrochlorothiazide, and sulfonamides.
7.Usage of any new skincare products during the course of the study.
8.Facial/laser treatment within the last 3 months
9.Facial cosmetic surgery within the last 12 months
10.Physical skin conditions such as excessive hair, scarring, tattoos that might impair evaluations of the test sites
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Change in Melasma Area and Severity Index (MASI) Score
Severity of melasma in each of the four regions (forehead, right malar region, left malar region and chin) is assessed on percentage of the total area involved (A), darkness (D), and homogeneity (H).
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Color assessment of facial hyperpigmentation
2. Patients Global Assessment of facial hyperpigmentation
3. Dermatology life quality index |
8 weeks |
|
|
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)
|
05/06/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Need of study : In modern allopathy medicines many topical steroid ointments are prescribed in the management of melasma. However, many such ointments cause adverse effect such as irritation, rashes etc. So a natural herbal based Ayurvedic or naturopathic facepack can be a safe, cost effective and better treatment. AIM and OBJECTIVE : The aim of this study is to evaluate the effect of Arjunadi lepa and naturopathy based face mudpack in management of vyanga.
RESEARCH QUESTION : 1. Does Arjunadi lepa have any effect in vyanga? 2. Does naturopathy face mudpack have any effect on vyanga? 3. Whether the effect of Arjunadi lepa is more or less as compared to naturopathy based face mudpack in management of vyanga? HYPOTHESIS : Null hypothesis ( Ho ) There is no difference between the effect of Arjunadi lepa and naturopathy based mudpack in management of vyanga. Research hypothesis ( H1 ) There is significant difference between the effect of Arjunadi lepa and naturopathy based mudpack in management of vyanga. |