| CTRI Number |
CTRI/2025/11/097948 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of haritaki taila nasya in Akala palitya that is premature greying of hair. |
|
Scientific Title of Study
|
Randomised Open Controlled Clinical Study To Evaluate The Efficacy Of Haritaki Taila Nasya In The Management Of Akala Palitya. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| Nill |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gauri Ramakant Nake |
| Designation |
PG Scholer |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8600965212 |
| Fax |
|
| Email |
nakegauri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya patil |
| Designation |
Associated professor in Panchakarma deparment |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Panchkarma OPD and Ipd Ground floor Panchakarma dept
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7406934574 |
| Fax |
|
| Email |
sukanyapatil250@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauri Ramakant Nake |
| Designation |
PG Scholer |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8600965212 |
| Fax |
|
| Email |
nakegauri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Gauri Ramakant Nake |
| Address |
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114 |
| Type of Sponsor |
Other [Self] |
|
|
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 Gauri Ramakant Nake |
Yashwant Dharmartha Rugnalay |
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
8600965212
nakegauri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur Maharashtra India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: AKALAPALITAH/PALITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki taila, Reference: Shardharshmita uttar khand , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Shaman chikitsa Dhatritiladiyoga 3Gm with madhu | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhringaraja taila , Reference: Shardharshmita madham khand,, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Shaman chikitsa Dhatritiladiyoga 3gm with madhu |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate in the study
Subjects indicated for nasya karma.
Irrespective of gender and religion. |
|
| ExclusionCriteria |
| Details |
Subjects suffering from skin diseases or any of the systemic diseases
Subjects with K/H/O anaemia or any other autoimmune diseases.
Subjects with K/H/O hormonal diseases or any hereditary disorder.
Subjects with age above 34 years.
Lactating mothers, female planning to conceive.
Subjects contraindicated for Nasya Karma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Haritaki Tail Nasya for 90days in Akala Palitya . |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the signs and symptoms of Akala Palitya.
To assess the improvement by signs, symptoms & gradation of assessment criteria.
To study etiopathology & clinical manifestation of Akala Pality.
To improve quality of life and reduce discomfort of Patients.
To achieve the outcome of study in 3 months. |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
04/12/2025 |
| 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)
|
Not Applicable |
| 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
|
Randomised Open Controlled Clinical Study To Evaluate The Efficacy Of Haritaki Taila Nasya In The Management Of Akala Palitya. Conclusion will be drawn on the basis of statistical analysis obtained at the end of clinical study. The results will be discussed on the basis of statistics and the study will be summarized accordingly. |