| CTRI Number |
CTRI/2025/03/083721 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study to Evaluate the Effectiveness of Krishna Mruttika Lepa in Treating Vyanga, with a Focus on Melasma |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of krishna mruttika lepa in the management of Vyanga with special refference to Mlasma |
| 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 Jasmeen S Akkalkot |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of Swasthavritta,room no 7,Sri Sri College of Ayurvedic Science and Research Hospital,Kanakapura Road,Udayapura P O Bangalore, KARNATAKA 560082 INDIA
Bangalore
KARNATAKA
560082
India |
| Phone |
9611466443 |
| Fax |
|
| Email |
jasmeenaliza@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajitha K |
| Designation |
Principal / Proffesor |
| Affiliation |
Sri Sri College of Ayurvedic science and research |
| Address |
Department of Swasthavritta,room no 7,Sri Sri College of Ayurvedic Science and Research Hospital,Kanakapura Road,Udayapura P O Bangalore, KARNATAKA 560082 INDIA
Bangalore
KARNATAKA
560082
India |
| Phone |
7760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajitha K |
| Designation |
Principal / Proffesor |
| Affiliation |
Sri Sri College of Ayurvedic science and research |
| Address |
Department of Swasthavritta,room no 7,Sri Sri College of Ayurvedic Science and Research Hospital,Kanakapura Road,Udayapura P O Bangalore, KARNATAKA 560082 INDIA
Bangalore
KARNATAKA
560082
India |
| Phone |
7760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri college of Ayurvedic Science and Research Centre.Kanakapura,Udayapura,P O 560082
|
|
|
Primary Sponsor
|
| Name |
Dr Jasmeen S Akkalkot |
| Address |
Sri Sri College Of Ayurvedic Science And Research Centre, Kanakapura,Udayapura,P O 560082 |
| 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 |
| Dr Jasmeen S Akkalkot |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of Swasthavritta,room no 7,Sri Sri College of Ayurvedic Science and Research Hospital,Kanakapura Road,Udayapura P O Bangalore, KARNATAKA 560082 INDIA
Bangalore
KARNATAKA |
9611466443
jasmeenaliza@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | , lepa | (Procedure Reference: Sushrutha Samhita , Procedure details: Take prosseced Krishna mrittika & mix it with water,make fine paste,and apply evenly on the cleaned face.keep it for sometime.wash face before lepa gets completely dried.)
(1) Medicine Name: Krishna Mrittika , Reference: Sushrutha Samhita , Route: Topical, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhava prakash nighantuë, Procedure details: Mix 10gms of jatiphala churna with water & make paste,and apply on the vyanga regions on the face,keep it for sometime,clean it before it gets dried completely.)
(1) Medicine Name: Jatiphala churna , Reference: Bhava prakash nighantuë , Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed with Melasma chronicity less than 5 years of age.
2.Subjects fulfilling the diagnosed criteria of Melasma with clinical features of VYANGA . |
|
| ExclusionCriteria |
| Details |
1 Individuals with hyper pigmentary disorders other than melasma
2 Females on oral contraceptive pills, pregnant women, lactating women
3 Hyperpigmentation since birth
4 individuals with endocrine disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant decrease in melasma pigmentation based on MASI Score.
Significant decrease in colour and number of lesions based on the arbitrary grading and fairness meter scale. |
0TH Day-First Visit
15TH Day -Second Visit
30TH Day-Third visit
45TH DAY-FOLLOW UP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| generation of in depthanalysed data on different aspects of diseaseand its treatment. |
45th day-follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/04/2027 |
| 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 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
|
Vyanga is a skin condition characterized by the presence of hyperpigmented patches on the face. It is considered a minor ailment in Ayurveda, categorized under "Kshudra Rogas." The condition is marked by painless, bluish-black patches that typically appear symmetrically on both sides of the face as Niruja tanu ,shyava ,mukhamagatya mandalas. In Ayurveda, Vyanga is believed to be caused by the vitiation of the Pitta and Vata doshas, which leads to the formation of these dark patches. The condition is often associated with factors such as excessive sun exposure, hormonal changes, and stress. Ayurvedic treatment for Vyanga includes both internal and external therapies. Internal treatments may involve the use of herbs and formulations that balance the doshas and purify the blood. External treatments often include the application of herbal pastes (Lepa), oils (Abhyanga), and other topical remedies that help lighten the pigmentation and improve skin health. krishna mruttika lepa is one of topical medicament ,taken here for the study of efficacy of krishna mruttika lepa in the management of vyanga.
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