| CTRI Number |
CTRI/2017/04/008441 [Registered on: 28/04/2017] Trial Registered Prospectively |
| Last Modified On: |
27/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to evaluate the effect of yashtimadhu amlaki churna in hairfall and to compare the mode of administration of yashtimadhukadi tail on hairfall through scalp and through nasal route. |
|
Scientific Title of Study
|
A Comparative Clinical Trial To Evaluate The Efficacy Of Nasya And Shiro-Abhayanga Of Yashtimadhukadi Tailam With Oral Administration Of Yashtimadhu-Amlaki Churna In Khalitya W.S.R. To Hairfall |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Rama Murthy |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Dr A. Rama Murthy, Assistant Professor, Dept of Dravya Guna Vigyana, National Institute of Ayurveda, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9314513659 |
| Fax |
|
| Email |
armurthy_2005@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parul Anand |
| Designation |
M.D Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Parul Anand, M.D Scholar, Dept of Dravya Guna Vigyana, National Institute of Ayurveda, Jaipur, 302002
National Institute of Ayurveda, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9086081993 |
| Fax |
|
| Email |
anand.parul.mailbox@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parul Anand |
| Designation |
M.D Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Parul Anand, M.D Scholar, Dept of Dravya Guna Vigyana, National Institute of Ayurveda, Jaipur, 302002
National Institute of Ayurveda, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9086081993 |
| Fax |
|
| Email |
anand.parul.mailbox@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Istitute of Ayurveda, near joravar singh gate amber road Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda Jaipur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Parul Anand |
Arogyashala, National Institute of Ayurveda Jaipur |
OPD no 25 Dept of Dravyaguna vigyana
Jaipur
RAJASTHAN |
09086081993
anand.parul.mailbox@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee National institute of Ayurveda Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Khalitya (Hairfall) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nasya with oral administration of yashtimadhu amlaki churna. |
Marsha nasya will be done using yashtimadhukadi tail for a period of 7 days. Yashtimadhu churna 4 gms and amlaki churna 6 gms will be given in two divided doses for a period of 60 days. |
| Intervention |
Shiro Abhyanga with oral administration of yashtimadhu amlaki churna. |
Shiro abhyanga will be done using yashtimadhukadi tail for a period of 30 days. Yashtimadhu churna 4 gms and amlaki churna 6 gms will be given orally in two divided doses for a period of 60 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who have classical signs and symptoms of khalitya since one month or more.
2)Patients within age group of 20 to 40 years of either sex.
|
|
| ExclusionCriteria |
| Details |
1)Patients below 20 years and above 40 years.
2)Patients who have diseases like Alopecia totalis, Tinea capitis, folliculisis devaculans and in Ayurvediya terms patients of Arunshika, Indralupta.
3)Patient suffering from any systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that trial drug will exert a significant action over hairfall with other associated symptoms. |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in the hairfall (through the procedure and the oral drug) will increase quality of life, self conidence and self esteem of the person with total gain of mental, physical and spiritual health. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/05/2017 |
| 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="0"
Days="10" |
|
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)?
|
|
Brief Summary
|
A comparative clinical trial to evaluate the efficacy of yashtimadhu amlaki churna in khalitya w.s.r to hairfall will be conducted. 60 patients will be selected randomly from Arogyashala OPD & IPD, National Institute of Ayurveda, Jaipur which will be well diagnosed having Khalitya (hairfall) as per the signs and symptoms described in Ayurvedic classical text. Duration of administration of oral drug will be 60 days. Yashtimadhu churna 4 gms and amlaki churna 6 gms will be given in two divided doses per day to the patients. All the participants will be divided into two groups. Group A will be given the above mentioned oral drug along with the nasya of yashtimadhukadi tail for 7 days. Group B will be given the above mentioned oral drug along with the shiro abhyanga of yashtimadhukadi tail for 30 days. Follow up will be done at 15, 30, 45 and 60 days after the completion of the trial. Written informed consent will be obtained. No economical aid will be given to the patient during the trial. ADR, if any will be recorded in the prescribed format and reported to RPVC, NIA, Jaipur. ADR, if any will be managed and / or referred suitably. |