| CTRI Number |
CTRI/2019/08/020702 [Registered on: 13/08/2019] Trial Registered Prospectively |
| Last Modified On: |
13/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of malatyadi tail and minoxidil solution in pattern baldness |
|
Scientific Title of Study
|
A comparative clinical study of malatyadi tail and minoxidil solution in the management of androgenetic alopecia (Khalitya). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashokkumar Bajaranglal Jangid |
| Designation |
PhD Scholar |
| Affiliation |
R A Podar Medical College (Ayu) |
| Address |
Room no 17,Kayachikitsa department R A Podar Medical College (Ayu),Dr Annie Besent Road,Worli,Mumbai 18,Maharashtra.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8286163751 |
| Fax |
|
| Email |
ashokbjangid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geet Parulkar |
| Designation |
Professor |
| Affiliation |
R A Podar Medical College (Ayu) |
| Address |
Kayachikitsa Department R A Podar Medical College (Ayu),Dr Annie Basent Road,Worli,Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8652694332 |
| Fax |
|
| Email |
geeta.parulkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashokkumar Bajaranglal Jangid |
| Designation |
PhD Scholar |
| Affiliation |
R A Podar Medical College (Ayu) |
| Address |
ROOM No 17 Kayachikitsa Department R A Podar Medical College (Ayu),Dr Annie Basent Road,Worli,Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8286163751 |
| Fax |
|
| Email |
ashokbjangid@gmail.com |
|
|
Source of Monetary or Material Support
|
| R A Podar Medical College (Ayu) And M A Podar Hospital Mumbai-18 |
|
|
Primary Sponsor
|
| Name |
R A Podar Medical College Ayu |
| Address |
R A Podar Medical College(Ayu),Dr Annie Basent Road,Worli,Mumbai |
| 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 |
| Ashokkumar Bajaranglal Jangid |
M A Podar Hospital |
Kayachikitsa OPD, IPD And Department, M A Podar Hospital, R A Podar College(Ayu),Dr Annie Besant Road,Worli,Mumbai
Mumbai
MAHARASHTRA |
8286163751
ashokbjangid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
malatyadi tail |
10ml topically once a day on alternate days for the duration of 120 days |
| Comparator Agent |
minoxidil solution |
minoxidil 5% solution once a day 1ml topically daily for the duration of 120 days |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
lakshanas of khalitya vyadhi as per ayurveda and modern medicine,subjective parameters hair fall and scalp visibility,Pull test,Norwood-Hamilton scale for men, Ludwigs diffuse vertical thining type for women,Savin density scale for female,patient willing for clinical trial and informed consent and complying with protocols. |
|
| ExclusionCriteria |
| Details |
any other serious illnes,major serious illness,cancer,anemia,thyroid disorders,major psychological disorders,psoriasis,diabetes,local bacterial infections,alopecia totalis,tinea capitis,folliculitis decalvans,alopecia areata,injury on head,and major systemic disorders if assessed clinically and hypersensitivity are excluded.patient havind mahakushtha,kaksha,indralupta,arunshika etc.pregnent women,lactating mother and as per the facility in the institute. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Signs and symptoms of androgenetic alopecia(khalitya) after using both drugs |
Three years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and efficacy of malatyadi tail and minoxidil solution |
Three years |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
15/08/2019 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
This is a randomised controlled open labelled parellel group clinical trial to study safety and efficacy of malatyadi tail and minoxidil solution. |