| CTRI Number |
CTRI/2024/06/068670 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Psychodermatology] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yastimadhu ghrita in the management of Melasma/ Mukha Vyanga |
|
Scientific Title of Study
|
A Single Blind Randomised Controlled Clinical Study to evaluate the Varnya and Medhya effect of Yastimadhu ghrita over Manjishta ghrita internally and externally in Mukha Vyanga with special reference to 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 |
Dr Sapna Xavier Lope |
| Designation |
PG Scholar |
| Affiliation |
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and PhD studies center Gadag |
| Address |
Department of kayachikitsa
Room No 3
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and PhD studies center Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
7676836564 |
| Fax |
|
| Email |
sapnalopes04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yasmeen A Phaniband |
| Designation |
Professor |
| Affiliation |
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and PhD studies center Gadag |
| Address |
Kayachikitsa OPD
Department of Kayachikitsa
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and PhD studies center Gadag
KARNATAKA
582103
India |
| Phone |
9845515865 |
| Fax |
|
| Email |
yasmeenphaniband@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna Xavier Lope |
| Designation |
PG Scholar |
| Affiliation |
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and PhD studies center Gadag |
| Address |
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and PhD studies center Gadag
KARNATAKA
582103
India |
| Phone |
7676836564 |
| Fax |
|
| Email |
sapnalopes04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri DGM Ayurvedic medical college and hospital Gadag Karnataka India
582103 |
|
|
Primary Sponsor
|
| Name |
DrSapna Xavier Lopes |
| Address |
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and PhD studies center Gadag Karnataka India
Pincode 582103 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrSapna Xavier Lopes |
Shri DGM Ayurvdic medical college and hospital |
Shri DGM Ayurvedic Medical College and Hospital Kayachikitsa OPD Gadag
Gadag
KARNATAKA |
7676836564
sapnalopes04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DGM Ayurvedic Medical college and Hospital PG and PhD center Ethical clearance committee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu Ghrita , Reference: Charaka sutrasthana 4/8 Ashtanga Sangraha sutrasthana 9/41, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm milk), Additional Information: The same ghrita is applied over the lesions two times a day | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjishta Ghrita , Reference: Charaka sutrasthana 4/8 Ashtanga Sangraha sutrasthana 9/41, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm milk ), Additional Information: The same ghrita is applied over the lesions two times a day |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Classical signs and symptoms of Vyanga like Shyava(brown coloured patches), tanuka(thin,non elevated), niruja(painless) mandalas on mukha, with or without kandu or daha or chimchimata associated with or without manasika hetus.
Subjects willing to participate and comply with all study procedures for prescribed trial period.
Subjects willing to give a written consent.
Age group between 18-55 yrs of either sex.
Subject not using any topical treatment for melasma for 2 weeks prior to enrolment to the study.
|
|
| ExclusionCriteria |
| Details |
Any medical conditions, laboratory findings or physical examination findings like vital signs, outside of specific range.
If subject is on any concomitant medications like oral contraceptives, thyroid medications and hormone replacement therapies.
Known allergic reaction to component of study product.
Treatment with other investigatory drug or other intervention within a specific time frame.
H/O drug or alcohol abuse.
Pregnant and lactating women.
Subject who have taken topical or oral steroids within 1 month prior to enrolment.
Subject who have taken topical tretinoin within 3 months or topical hydroquinone within 6 months prior to enrolment.
Subject under treatment of another dermatological condition.
Post Inflammatory Hyperpigmentation(PIH).
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in signs and symptoms of Melasma such as reduction in the size and colour of the lesion and other symptoms like roughness, itching, tingling if present, observing the safety or no side effects of the intervention undertaken.
Improvement in the Melasma Quality Of Life Scale. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gaining Twak sara purusha lakshana(Good skin health) like unctousness, smoothness, softness, clean, delcate & lustre.
Improvement in sleep & appetite of patient. |
120 days |
|
|
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 4 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="2"
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
|
Mukha vyanga is caused due to the conjugation
of vata dosha, pitta dosha and rakta dosha. Acharyas
explained the causes of vyanga like krodha(aggression/irritability), ayasa(Mental
Stress), shoka(feeling low) etc., which are lakshanas of manasa
karma atiyoga and mithyayoga. Hence it can be drawn that Manas
also plays an important role in the pathology of vyanga. Vyanga is
characterised as Niruja(painless), Tanuka(thin), Shyava mandals(blackish grey
patches) on mukha(face). Considering the Lakshana
samanyata, Vyanga, according to modern science can be correlated to Melasma. Observing these points,Yashtimadhu in the form
of ghrita is considered. Yashtimadhu has Madhurarasa,Varnya, Kandughna, Shonitastapana
properties along with Medhya and Rasayani gunas and Ghrita is considered
to possess Vatapitta prashamaka, Varnya, Medhya strengthens
brain and nervous system with deepaniya properties which may helpin the aamanagement of Vyanga lesions.
|