| CTRI Number |
CTRI/2025/07/090070 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Single Arm Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To observe hair and greying of hair in individuals consuming excess amount of salt. |
|
Scientific Title of Study
|
An observational study of kesha and palitya in young individual cosuming atilavan ahar. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Riya Gopal Goenka |
| Designation |
MD Scholar (Kriyasharir) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
| Address |
Department of Kriyasharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9284304764 |
| Fax |
|
| Email |
riyagoenka03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Abhijit Chitnis |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
| Address |
Department of Kriyasharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
09822354577 |
| Fax |
|
| Email |
abhijitchitnis692@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Abhijit Chitnis |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
| Address |
Department of Kriyasharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
09822354577 |
| Fax |
|
| Email |
abhijitchitnis692@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vd Riya Gopal Goenka |
| Address |
Department of Kriyasharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Maharashtra 411028 |
| Type of Sponsor |
Other [Principal Investigator 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 Riya Gopal Goenka |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
Department of Kriyasharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Maharashtra 411028
Pune
MAHARASHTRA |
09284304764
riyagoenka03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe, SSAM Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human consuming atilavan ahar. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Individuals ofage 18-25years
irrespective of gender,religion, economic status, dehaprakriti |
|
| ExclusionCriteria |
| Details |
Patients having any major systemic disease, Hereditary diseases.
Patient under treatment of other medication.
Patients with infective scalp diseases.
Viharaj, mansik and other hetu. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Detail study of concept of kesh from ayurvedic text, journals, papers, articles, etc.
Detail examination of hair with the help case record form (Trividhpariksha) and Trichoscope.
Status of palitya studied on basis of scalp gradation scale and colour scale of hair.
To develop a validated questionnaire to evaluate palitya in individual consuming atilavanahara. |
nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/07/2025 |
| 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="4"
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
|
* Hair is important to the appearance of individual. As Ayurveda text mention Lavan rasa is one of main cause for palitya, people are fond of finger snacks (chips, Kurkure, nachos, etc). They may eat 2-3 or more packets throughout day as a time saving diet. So, to study kesh and palitya due to atilavan ahara this study is carried out. Greying of hair back to normal is difficult but by proper ahara the uttpati of hair is improved. |