| CTRI Number |
CTRI/2024/07/071662 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of medicated herbal lepa in hyperpigmentation management |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Varun Twak Lepa with
Aja Dugdha and Go Dugdha in the management of Vyanga wsr 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 |
Manisha Kumawat |
| Designation |
MD scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be University |
| Address |
Dept. of Dravyaguna, National Institute of Ayurveda, Joravar Singh gate, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955510432 |
| Fax |
|
| Email |
manishakumawat2496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Deemed to be University |
| Address |
Dept. of Dravyaguna, National Institute of Ayurveda, Joravar Singh gate, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani2@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Deemed to be University |
| Address |
Dept. of Dravyaguna, National Institute of Ayurveda, Joravar Singh gate, Jaipur
RAJASTHAN
302002
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani2@rediff.com |
|
|
Source of Monetary or Material Support
|
| Pharmacy of National Institute of Ayurveda Deemed to be university ,
Madhav Vilas Palace, Amer Rd, Jaipur, Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be university |
| Address |
Jorawar singh gate, Jaipur, Rajasthan, 302002 |
| 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 |
| Manisha Kumawat |
National Institute of Ayurveda |
OPD no.19 National Institute of Ayurveda jaipur,Department of Dravyaguna.
Jaipur
RAJASTHAN |
8955510432
manishakumawat2496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Varun twak churna, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -go dughda ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: varun tvak lepa, Reference: chakradutta, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Ajadugdha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting Vyanga as clinical features according to Susruta Samhita (Mandalam Visrujati, Nirujam Tanu ,Shyava).
2.
Patients of either sex.
3.
Patients of age between 18 - 60 years.
4.
Patients that come under the criteria of MASI scale. |
|
| ExclusionCriteria |
| Details |
Melasma due to tubercular therapy or malignant cases.
2.
Patients having systemic pathogenesis due to allergy.
3.
Diagnosed patients of Carcinoma, Burns, Herpes, Eczema, Psoriasis, Measles, Chickenpox, Leucoderma and Leprosy.
4.
Person suffering from any infective or contagious skin disease or under medication with antibiotics, antifungal and steroid.
5.
Patients of uncontrolled hormonal disease.
6.
Patients who are reporting allergic history of trial drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in MASI scale . |
Changes in MASI scale after 4th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Ayurvedic parameters i.e. varna, akriti.
â–ª
Changes in quality of life index (MELASQOL). |
2 months |
|
|
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)
|
10/08/2024 |
| 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)
|
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
|
Today, the whole world is looking towards Ayurveda with great expectations; they have realized the significance of Ayurveda. People search for the Ayurveda as it maintains longevity, beautification and minimal adverse effects of the drugs. The prime objective of Ayurveda is to maintain and reestablish the equilibrium of body tissue that is why our sages have described Trisutra1 not only for all healthy person but also for ailing. Beauty is one of the most valued aspects in this competitive era. There is nothing like healthy skin to make an individual feel confident and beautiful, so it is no surprise that uneven skin tone can make any women and man feel self-conscious. Uneven skin tone is always frustrating factor for youth. Acharya Sushruta and Acharya Vagbhatta has mentioned Vyanga as Kshudra Roga. All most all Acharyas have considered Vyanga as a Kshudra Roag except,Acharya Charakahas mentioned vyanga under raktadhatugata2vikara. According to Ayurveda concepts,it is manifested due to vitiation of vata and pitta dosha. These doshas vitiated by krodha,aayas,ushna, tikshna,ruksha dietary habits. Thereby, it results in presence of niruja,tanu and shyava varan yukta mandala on mukha pradesh3. Need of Study: - ➢ Vyanga (Melasma) is a condition which affects the beauty as well as personality. Now a days Vyanga has become one of the biggest problems specially in women due to excessive use of cosmetic supplements and changes occurring during pregnancy. ➢ There is a need to explore natural alternative as per Ayurveda classics for safe management of vyanga which is also easily available and cost effective. ➢ Procuring and using goat milk is a biggest challenge in today’s busy schedule and need of the hour is to fulfill this gap with maintaining characteristics of final product (lepa Kalpana) ➢ This gap can be fulfilled with the help of searching an alternative for the Aja dugdha in the form of Go dugdha as well as exploring options to increase the shelf life for Varun twak with Aja Dhughda lepa. |