| CTRI Number |
CTRI/2024/10/075827 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Nasya (Markava Taila) And Keshranjan Lepa (Kalpita Yoga) In The Management Of Palitya (Graying Of Hair) |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Nasya (Markava Taila) With Keshranjan Lepa (Kalpita Yoga) And Nasya In The Management Of Palitya (Graying Of Hair) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anju Saini |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005524924 |
| Fax |
|
| Email |
anjus8029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju Saini |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005524924 |
| Fax |
|
| Email |
anjus8029@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Kadvad
Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 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 Anju Saini |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
PG Department of Panchkarma Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN |
8005524924
anjus8029@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L671||Variations in hair color. Ayurveda Condition: SIROROGOTTHA-PALITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charak Chikitsa 26, Procedure details: 30 Patients will be treated with Nasya with Markava Taila )
(1) Medicine Name: Markava Taila, Reference: Chakradutta 55, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Charak Chikitsa 26, Procedure details: 30 Patients will be treated with Nasya (Markava Taila) & Keshranjana Lepa (Kalpita Yoga))
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed and confirmed case of Palitya on the basis of the sign and symptoms
Clinically fit for Nasya and Lepa procedure
Patients without malignancy or patients without going through any treatment
Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent performa |
|
| ExclusionCriteria |
| Details |
Female
Subjects contraindicated for Nasya and Lepa
Patients suffering with the symptoms of jwara vrana and any type of head injury will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect on subjective and objective parametres |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see any other effects of drug and procedures |
14 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Type - Interventional
Number Of Patients - 60(30 Patients in each group)
Type Of Study- Open Labelled
Duration Of Study- 14 Days (30 Patients will be treated with Nasya for 14 days and 30 Patients will be treated with Nasya and Lepa) |