| CTRI Number |
CTRI/2021/12/038435 [Registered on: 03/12/2021] Trial Registered Prospectively |
| Last Modified On: |
03/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of Tila Taila on hairfall |
|
Scientific Title of Study
|
A CLINICAL STUDY ON EFFECT OF TILA TAILA ON KESHPATAN W.S.R. KESH AS MALA OF ASTHI DHATU |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Sharma |
| Designation |
M.D. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayueved College Udaipur |
| Address |
PG dept. of Kriya sharir Madan Mohan Malviya Govt. Ayurved College Udaipur Rajasthan
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
7014337116 |
| Fax |
|
| Email |
manishsharma33684@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok kumar sharma |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
PG dept. of kriya sharir Madan Mohan Malviya Govt. Ayurved college Udaipur
Rajasthan
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413205904 |
| Fax |
|
| Email |
sharmadrak06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K L Sharma |
| Designation |
Associate professor |
| Affiliation |
M.M.M. Govt. Ayurved College Udaipur |
| Address |
PG dept. of kriya sharir Madan Mohan Malviya Govt. Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976392353 |
| Fax |
|
| Email |
drklalsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| MADAN MOHAN MALVIYA GOVT AYURVED COLLEGE UDAIPUR |
|
|
Primary Sponsor
|
| Name |
MADAN MOHAN MALVIYA GOVT AYURVED COLLEGE UDAIPUR |
| Address |
MADAN MOHAN MALVIYA GOVT. AYURVED COLLEGE UDAIPUR RAJASTHAN INDIA |
| Type of Sponsor |
Government 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 Manish sharma |
madan mohan malviya govt. ayurved college udaipur |
madan Mohan malviya govt. ayurved college udaipur rajasthan
Udaipur
RAJASTHAN |
7014337116
manishsharma33684@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Madan Mohan Malviya Government Ayurveda college Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E639||Nutritional deficiency, unspecified. Ayurveda Condition: Keshpatan, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Tila taila (sesame oil) |
Shirobhyanga with Tila taila for 2 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. 30 prakrit person(healthy indivisual) having symptom of keshpatan(hairloss).
2. observation will be noted - Hair loss, Hair pull test, hair count test, oilyness, brittlness, bifurcation , lustre. |
|
| ExclusionCriteria |
| Details |
1. As per ashtanghridya contraindication of Shirobhyanga.
2. The person suffering from other metabolic and hormonal diseases.
3. age below 20 yrs and above 40 yrs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective critaria:
1. keshpatan (hair loss)
2. lustre
3. bifurcation
4. brittleness |
8 Weeks (2 Months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. acceptability/tolerance of treatment.
2. Cost effective treatment |
8 Weeks (2 Months) |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/12/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a clinical trial , to study the effect of tila taila on keshpatan (hair loss) by shirobhyanga of tila taila. evaluate the clinical efficacy of tila taila and understand its mechanism of action in ayurveda . 30 patient of keshpatan (hair loss) will be treated by shirobhyanga of tila taila. |