| CTRI Number |
CTRI/2021/12/038434 [Registered on: 03/12/2021] Trial Registered Prospectively |
| Last Modified On: |
26/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check the effect of Adityapak Guduchi Tailam ( Shiroabhyangam ) & Yashtimadhukadhya Tailam ( Nasayam ) in the treatment of Hairfall |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Adityapak Guduchi Tailam ( Shiroabhyangam ) & Yashtimadhukadhya Tailam (Nasayam) in the management of Khalitya w.s.r. Hairfall |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
poonam verma |
| Designation |
P.G. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
P.G. Dept. of kayachikitsa
Madan Mohan Malviya Govt. Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9587957774 |
| Fax |
|
| Email |
drpoonamhiteshverma09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Sharma |
| Designation |
H.O.D. & Guide |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
P.G. Dept. of kayachikitsa
Madan Mohan Malviya Govt. Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414419259 |
| Fax |
|
| Email |
rspgkcj2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Sharma |
| Designation |
H.O.D. & Guide |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
P.G. Dept. of kayachikitsa
Madan Mohan Malviya Govt. Ayurved College Udaipur
RAJASTHAN
313001
India |
| Phone |
9414419259 |
| Fax |
|
| Email |
rspgkcj2015@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 Radajicircle Udaipur |
| 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 Ravi Sharma |
Govt. Ayurved Hospital Motichohtta Udaipur |
OPD Room No 1 ,Govt. Ayurved Hospital Motichohtta ,PG Dept. of Kaya Chikitsa Madan Mohan Malviya Govt. Ayurved College Udaipur
Udaipur
RAJASTHAN |
9414419259
rspgkcj2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Madan Mohan Malviya Govt. Ayurved College Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Siro~aBya~ggaH, शिरोरऽà¤à¥à¤¯à¤‚ग | (Procedure Reference: Adityapak Guduchi Tailam Chakradutt Kshudra Roga 107, Procedure details: Apply gently on scalp.
Dose- 5ml/day (female)
2ml/day (male)
Duration- 2 months
)
| | 2 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Yashtimadhukadhya Tailam Chakradutt Kshudhra Roga 111, Procedure details: For nasya
Dose- 2 drop twice in a day
Duration- 2 months
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing for trial.
2. Patients age above 20 and below 45 years.
3. Patients having sign & symptoms of khalitya.
4. Either sex of different socio-economic groups
|
|
| ExclusionCriteria |
| Details |
1. Patient below age of 20 and above 45 years.
2. Patient suffering from- hypothyroidism, typhoid, cancer etc.
3. Alcoholics and drug abusers.
|
|
|
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 |
| Relief in sign and symptoms |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of treatment |
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
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2021 |
| 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="2"
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)?
Response - NO
|
|
Brief Summary
|
This study is about evaluate the efficacy of Adityapak Guduchi Tailam (Shiroabhyangam) & Yashtimadhukadhya Tailam ( Nasayam) in the management of Khalitya w.s.r. Hairfall. In this Trial 30 Patients have been given both Shiroabhyangam & Nasayam. The trial is of 2 months. This is Single Arm Trial. |