| CTRI Number |
CTRI/2021/06/033988 [Registered on: 04/06/2021] Trial Registered Prospectively |
| Last Modified On: |
03/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Study of ayurvedic cosmetology and evaluation of keshnashak lepa. |
|
Scientific Title of Study
|
Comprehensive study of cosmetology in Ayurveda w.s.r to evaluation of keshnashak lepa. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Rajesh sood |
| Designation |
Head of department |
| Affiliation |
Rajiv gandhi government post graduate ayurvedic college and hospital paprola Kangra |
| Address |
ROOM NO 404 Anatomy Block Department of Samhita and Siddhant Rajiv gandhi government post graduate ayurvedic college and hospital paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418102424 |
| Fax |
|
| Email |
drrajeshsood@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajesh sood |
| Designation |
Head of department |
| Affiliation |
Rajiv gandhi government post graduate ayurvedic college and hospital paprola Kangra |
| Address |
ROOM NO 404 Anatomy Block Department of Samhita and Siddhant Rajiv gandhi government post graduate ayurvedic college and hospital paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418102424 |
| Fax |
|
| Email |
drrajeshsood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika sharma |
| Designation |
Pg scholar |
| Affiliation |
Rajiv gandhi government post graduate ayurvedic college and hospital paprola Kangra |
| Address |
ROOM NO 405 Anatomy Block Department of Samhita and Siddhant Rajiv gandhi government post graduate ayurvedic college and hospital paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8580547110 |
| Fax |
|
| Email |
ritzsharma159@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College And hospital Paprola, District Kangra, H.P. |
| Research Institute in I.S.M. Jogindernagar, Dist. Mandi, H.P. |
|
|
Primary Sponsor
|
| Name |
RGGPG AYURVEDIC COLLEGE |
| Address |
Rajiv gandhi government post graduate ayurvedic college and hospital paprola teh baijnath distt kangra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
Department of Samhita and Siddhant Rggpg ayurvedic college and hospital paprola Kangra |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Rajesh Sood |
Rajiv gandhi government post graduate ayurvedic college |
OPD no.715 skin care unit and derma research lab hospital block
Kangra
HIMACHAL PRADESH |
9418102424
drrajeshsood@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (human) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair and hair follice |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eflornithine cream |
15 patients will be given eflornithine cream.Local application.Dose as per requirement. Duration of drug application-7days |
| Intervention |
Keshnashak lepa |
15 patients will be given Keshnashak lepa.Local application.Dose as per requirement. Duration of drug application-7days.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Individuals willing to participate in trial.2.Only females will be included in trial.3.Individuals having the age between 15-50 year.4.Individuals showing negative results to the skin sensitivity test.
5. Women having visible unwanted male pattern hair growth on face,chest and back irrespective of underlying cause will also be included in trial, but the drug will only be used
on extremities in present study. |
|
| ExclusionCriteria |
| Details |
1.Individuals showing positive results to skin sensitivity test. (having skin sensitive to thedrug)2. Pregnancy and lactation will be excluded.3. Diabetic patients will beexcluded.4. Individuals having any type of skin lesions over extremities will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall improvement which will be shown by the
patients in signs and symptoms |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall improvement which will be shown by the
patients in signs and symptoms |
2 month |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
10/06/2021 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hair occupy great cosmetological value in making a person look beautiful with attractivepersonality, but excessive body hair can exactly do the opposite to a person. In present era various hair removal products and procedures are there as per the need of hour. But these are gruesome to the individual. For beautification purpose these products are being used very commonly and on regular basis. The present study has been planned to evaluate the effect of keshnashak lepa for cosmetic purpose and also to see the effect of this lepa on hair growth and duration of hair regrowth. |