| CTRI Number |
CTRI/2025/03/082941 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Vitamin B12 and Heamoglobin in Akala Palitya (Premature Canities) |
|
Scientific Title of Study
|
A Case Control Study to assess the association of Serum Vitamin B12 and Heamoglobin in Akala Palitya (Premature Canities) |
| 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 Sakshi Jain |
| Designation |
Post Graduate Scholar in Department of Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Pt Khusilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
| Address |
Room Number 6
Department of Rog Nidan Evum Vikriti Vigyan
Science Hills
Behind MANIT
Kolar Nehru Nagar Bypass Road
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8319583628 |
| Fax |
|
| Email |
drsakshijain1008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rita Singh |
| Designation |
Associate Professor of Rog Nidan Evum Vikriti Vigyan Department |
| Affiliation |
Pt Khusilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
| Address |
Room Number 6
Department of Rog Nidan Evum Vikriti Vigyan
Science Hills
Behind MANIT
Kolar Nehru Nagar Bypass Road
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8435990799 |
| Fax |
|
| Email |
vd.ritu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rita Singh |
| Designation |
Associate Professor of Rog Nidan Evum Vikriti Vigyan Department |
| Affiliation |
Pt Khusilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
| Address |
Room Number 6
Department of Rog Nidan Evum Vikriti Vigyan
Science Hills
Behind MANIT
Kolar Nehru Nagar Bypass Road
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8435990799 |
| Fax |
|
| Email |
vd.ritu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt Khusilal Sharma Government Autonomous Ayurveda College and Institute
Science Hills
Behind MANIT
Kolar Nehru Nagar Bypass Road
462003
Bhopal
Madhya Pradesh
India
|
|
|
Primary Sponsor
|
| Name |
PT KHUSILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITITE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT.KOLAR NEHRU NAGAR BYPASS
ROAD, BHOPAL MADHYAPRADESH 462003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sakshi Jain |
Pt Khusilal Sharma Government Autonomous Ayurveda College and Institute Bhopal 462003 |
Room Number 22
Pathology Laboratory
Department of Rognidan Evum Vikriti Vigyan
Science Hills
Behind MANIT
Kolar Nehru Nagar Bypass Road
462003
Bhopal
MADHYA PRADESH |
8319583628
drsakshijain1008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient presenting with sign and symptoms of Akala Palitya (Premature Hair Greying) as described in Ayurveda as well as Modern Medical Science.
2. Patients between the age group of 16-25 years, either sex and irrespective of socio economics status.
3. Healthy individual between the age group of 16-25 years, either sex and irrespective of socio economic status.
4. Patients and healthy individual willing to sign consent form for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients not fulfilling the inclusion criteria.
2. Patients with graying of hair as a part of other conditions such as Vitiligo, Auto Immune thyroid diseases, and premature aging syndromes like Werner syndrome etc.
3. Pregnant or lactating women.
4. Patients and Healthy individual not willing to sign the consent form for the Study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of this Study we would be able to explain the association of
Deficiency of Serum Vitamin B12 and Heamoglobin in pathogenesis of Akala Palitya (Premature
Canities)
|
It is expected that at the end of this Study we would be able to explain the association of
Deficiency of Serum Vitamin B12 and Heamoglobin in pathogenesis of Akala Palitya (Premature
Canities)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is further expected that this study will be helpful in clinical practice for the
Akala Palitya (Premature Canities)
|
It is further expected that this study will be helpful in clinical practice for the
Akala Palitya (Premature Canities)
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/03/2025 |
| 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="0"
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
|
It
is expected that at the end of this Study we would be able to explain the
association of
Deficiency
of Serum Vitamin B12, and Heamoglobin in pathogenesis of Akala Palitya
(Premature
Canities)
It
is further expected that this study will be helpful in clinical practice for
the
Akala
Palitya
(Premature Canities) |