| CTRI Number |
CTRI/2025/11/096850 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of combined Ayurveda protocol in the management of premature greying of hair |
|
Scientific Title of Study
|
A Clinical Study To Evaluate Combined Protocol Of Jalauka-Avacharana,Pratimarsha Nasya and Shiro Lepa in Akala Palitya (Premature Greying 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 Khushi Trivedi |
| Designation |
PG scholar |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and research |
| Address |
GJ Patel Institute of Ayurvedic studies and research, New Vallabh Vidyanagar B/h. GIDC, ADIT Campus, Anand, Gujarat
Anand
GUJARAT
388121
India |
| Phone |
8141962844 |
| Fax |
|
| Email |
khuhi203@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Gandhe |
| Designation |
Head of the department |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and research |
| Address |
GJ Patel Institute of Ayurvedic studies and research, New Vallabh Vidyanagar B/h. GIDC, ADIT Campus, Anand, Gujarat
Anand
GUJARAT
388121
India |
| Phone |
9422062452 |
| Fax |
|
| Email |
gayatri.gandhe@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushi Trivedi |
| Designation |
PG scholar |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and research |
| Address |
GJ Patel Institute of Ayurvedic studies and research, New Vallabh Vidyanagar B/h. GIDC, ADIT Campus, Anand, Gujarat
Anand
GUJARAT
388121
India |
| Phone |
8141962844 |
| Fax |
|
| Email |
khuhi203@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Khushi Trivedi |
| Address |
GJ Patel Institute of Ayurvedic studies and research, New Vallabh Vidyanagar B/h. GIDC, ADIT Campus, Anand-388121, Gujarat |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Khushi Trivedi |
S. G. Patel Ayurveda Hospital and Maternity Home |
Department of Panchakarma,OPD NO. 15, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar B/h. GIDC, ADIT Campus, Anand-388121, Gujarat
Anand
GUJARAT |
8141962844
khuhi203@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G. J. PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH INSTITUTIONAL ETHICAL COMMITTEE |
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: AKALAPALITAH/PALITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Sushruta samhita sutra sthana 13/6, Procedure details: 1 sitting of jaluaka avacharana)
| | 2 | Intervention Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Ashtanga Hrudaya, sutra sthana 20/39, Procedure details: Participants will be asked to lie comfortably in supine position with head and neck
low position. Oil will be instilled in the each nostrils.The excess oil which comes in the throat and mouth should be spit out.)
(1) Medicine Name: Bhrungaraj taila, Reference: Chakradatta, netra roga, Route: Nasal, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 30 Days | | 3 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: charaka samhita,chikitsa sthana 26/262, Procedure details: The lepa churna should be mixed with appropriate quantity of water to form a paste.Than paste should be applied over scalp region.The participants will be asked to wash the lepa with plain water when it becomes dry.)
(1) Medicine Name: lohadi lepa, Reference: vangasena Samhita, Kshudra roga, Route: Topical, Dosage Form: Lepa Churna, Dose: 30(g), Frequency: od, Duration: 4 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Subject diagnosed as having Akala Palitya between the age group 15-45 years, irrespective of sex
2)Patients who have not used hair dyes in last 2 months.
3)Patients who are willing to give the informed consent. |
|
| ExclusionCriteria |
| Details |
1)Patients having any skin disease and wounds in scalp.
2)Any history of allergy.
3)Hypersensitivity of skin.
4)Any major disease such as hypertension, diabetes mellitus, Hematological disorder will be excluded. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Greying Severity Score (GSS)
|
0th day, 8th day, 38th day, 45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Rooksha Sputhita (dry splitted hair)
2.Snigdha (oiliness)
3. Daha (burning sensation of scalp) |
0th day, 8th day, 38th day, 45th day
|
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Title A clinical study to evaluate combined protocol of jalauka avacharana pratimarsha nasya and shiro lepa in akala palitya ( premature greying of hair)
Background Premature greying of hair is increasingly common due to stress, poor nutrition, environmental factor and life style .According to ayurveda, palitya is a Rasapradoshaja vikara and kshudraroga, primarily due to pitta dosha vitiation. Acharya has described raktamokshana, nasya, lepa, nasya as the line of treatment for palitya.
Research problem There is no permanent or curative modern treatment for premature greying . Hence this study evaluates the effectiveness of a combined protocol to manage palitya
Study Design Protocol based single arm study
Methodology Triphala Rasayana: for 38 days jalauka avacharana: for 1 day Pratimarsha nasya : for 30 days Shiro lepa: for 4 days
Total treatment period: 38 days
Assessment and follow up on 0 day, 8th day, 38th day, 45th day(after treatment follow up)
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