| CTRI Number |
CTRI/2023/06/053638 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
30/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ayurveda management on acne with mukhadooshikari lepa |
|
Scientific Title of Study
|
clinical study to evaluate the effect of modified mukhadooshikari lepa in youvana pidaka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AJAY RAJ |
| Designation |
UG SCHOLAR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Third year UG scholar
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan - 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8529235639 |
| Fax |
|
| Email |
ajayraj253.ar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAILAJA U |
| Designation |
PROFESSOR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Professor, Vice Principal, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan - 573201
Professor, Vice Principal, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan - 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
drshailajau@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAILAJA U |
| Designation |
PROFESSOR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Professor, Vice Principal, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan - 573201
Professor, Vice Principal, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan - 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
drshailajau@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan - 573201 |
|
|
Primary Sponsor
|
| Name |
RGUHS |
| Address |
Jaya Nagar,4th T Block,Near-Tilak Nagar Post Office, Bengaluru, Karnataka 560011 |
| Type of Sponsor |
Private 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 SHAILAJA U |
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital |
OPD 16
Department of Kaumarabhritya
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan - 573201
Hassan
KARNATAKA |
9448816433
drshailajau@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
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: PIDAKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MUKHADOOSHIKARI LEPA, Reference: ASHTANGA HRDAYA, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients complaining of pidaka over the face with history of more than one year.
2.Patients between the age group of 17 and 30 years |
|
| ExclusionCriteria |
| Details |
1.Patients having pidaka of other khusdra roga and kusta
2.Patients having pidaka on places other than face.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the size of youvana pidaka, after the applicationof mukhadooshikari lepa |
baseline, 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modification of lepa into Gel |
0/15DAY |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
07/06/2023 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
youvana pidaka (acne vulgaris), is most common skin care problem seen in age group of 17 -30 years old. it is caused by kapha - vata- rakta dusti of individual.in ashtanga hrdaya, mukhadooshikari lepa application is advised, as an external therapy. Considering the disadvantages of lepa, it is replaced with the gel form, because of its Four Major Benefits including Lightweight , Quickly absorbed , Non greasy , Hydrating for longer period.Mukhadooshikari lepa contains extract of vacha , manjishta, lodra, pushkaramoola, dhanyaka , usheera ,masura, vata along with carbopol 940, propylene glycol, ethanol, methylparaben, propylparaben. Here by an attempt is made to evaluate the effectiveness of mukhadooshikari lepa in youvana pidaka, 10 participants will be selected and advise for the external application of mukhadooshikari lepa -3gm -twice daily and the assessment will be recorded on the 0th day and 15th day and will be analysed. |