| CTRI Number |
CTRI/2022/02/040390 [Registered on: 17/02/2022] Trial Registered Prospectively |
| Last Modified On: |
14/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of homoeopathic medicine in cases of premature greying of hair |
|
Scientific Title of Study
|
Role of constitutional medicine with lifestyle modification in cases of premature greying of hair |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrChirag H Tamboli |
| Designation |
Professor and HOD of organon of medicine |
| Affiliation |
Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL |
| Address |
Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL AND DR V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AMUL DAIRY ROAD ANAND
C-1/104 svayam Symphony
Anand sajitra road
Anand
Anand
GUJARAT
388001
India |
| Phone |
9898515586 |
| Fax |
|
| Email |
drchiragtamboli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChirag H Tamboli |
| Designation |
Professor and HOD of organon of medicine |
| Affiliation |
Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL |
| Address |
Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL AND DR V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AMUL DAIRY ROAD ANAND
C-1/104 svayam Symphony
Anand sajitra road
Anand
Anand
GUJARAT
388001
India |
| Phone |
9898515586 |
| Fax |
|
| Email |
drchiragtamboli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pinkal Bhoya |
| Designation |
PG student |
| Affiliation |
Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL |
| Address |
Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL AND DR V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AMUL DAIRY ROAD ANAND
Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL AND DR V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AMUL DAIRY ROAD ANAND
Anand
GUJARAT
388001
India |
| Phone |
7984484548 |
| Fax |
|
| Email |
bhoyapinkal@outlook.com |
|
|
Source of Monetary or Material Support
|
| Dr.V.H.Dave Homoeopathic Medical College associated with Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Pinkalben Bhoya |
| Address |
At po Hanumabari nishal faliya
Ta vansda
Di Navsari
Gujrat
Pincode 396580 |
| 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 Chirag H Tamboli |
Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL |
OPD NO 001 Department Of Medicine Smt S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL AND DR V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AMUL DAIRY ROAD ANAND
Anand
GUJARAT |
9898515586
drchiragtamboli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VHDHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L671||Variations in hair color, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional medicine selected on basis of totality of symptoms |
Medicine will be given in potency 30C 200C 1M , Mode of administration oral route , Repetition and duration of therapy as per case required |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
People whose complaint started before 35 years of age will be included.
2. Both male and female gender will be considered
3. Patients who are taking any other treatment for any disease condition and wants to take medicine for premature greying of hair. |
|
| ExclusionCriteria |
| Details |
The patient above 35 years will be excluded. Cases with severe systemic disease or with irreversible pathology. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Photographic evidence before and after treatment |
At the beginning and at the end of the treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Photographic evidence |
at the end of treatment |
|
|
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)
|
28/02/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As hair issues are highly common now-a-days and even people in their teens and youngsters are becoming a victim of these problem. Premature canities is the most common condition among hair issues and because of this people are having significant adverse effects on the appearance, self esteem, and socio- cultural acceptance. The prevalence of premature canities is remarkably increasing in modern times as compared to those in earlier days. This condition can arise from overall mental and physical derangement of health which can only be cured by holistic approach that is by prescribing homoeopathic constitutional medicine. |