| CTRI Number |
CTRI/2024/10/075956 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Other (Specify) [Therapeutic effectiveness] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of dandruff reducing effect of Homoeopathic Drug Azadirachta indica 200 C under laboratory setting with clinical study of the same in patients with dandruff |
|
Scientific Title of Study
|
In vitro evaluation of antifungal activity of homoeopathic
medicine Azadirachta indica against pityrosporum ovale and
randomised controlled trial in patients with dandruff
|
| 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 Rasina farsath K P |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic medical college Karaparamba Kozhikode |
| Address |
Department of Homoeopathic repertory and case taking
Government Homoeopathic Medical College
Karaparamba Kozhikode
Kozhikode
KERALA
673010
India
Kozhikode
KERALA
673010
India |
| Phone |
7012044900 |
| Fax |
|
| Email |
raazna6797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansoor Ali KR |
| Designation |
Professor and HOD |
| Affiliation |
Gov Homoeopathic medical college Kozhikode |
| Address |
Department of Homoeopathic repertory and case taking
Government Homoeopathic Medical College
Karaparamba Kozhikode
Kozhikode
KERALA
673010
India
Kozhikode
KERALA
673010
India |
| Phone |
9249337799 |
| Fax |
|
| Email |
drmansoorkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rasina farsath K P |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic medical college Karaparamba Kozhikode |
| Address |
Department of Homoeopathic repertory and case taking
Government Homoeopathic Medical College
Karaparamba Kozhikode
Kozhikode
KERALA
673010
India
Kozhikode
KERALA
673010
India |
| Phone |
7012044900 |
| Fax |
|
| Email |
raazna6797@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government homoeopathic medical college kozhikode kerala pin 673010 india |
|
|
Primary Sponsor
|
| Name |
Dr Rasina farsath K P |
| Address |
Government homoeopathic medical college karaparamba kozhikode kerala pin 673010 India |
| 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 Rasina farsath KP |
Gov Homoeopathic medical college , Karaparamba,Kozhikode |
Skin OP Room no 1 Department of Homoeopathic repertory and case taking
Government Homoeopathic Medical College
Karaparamba Kozhikode
Kozhikode
KERALA
673010
India
Kozhikode
KERALA |
7012044900
raazna6797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Azadirachta Indica |
Azadirachta indica 200 C in sugar of milk twice in a week for a duration of 2 month |
| Comparator Agent |
constitutional medicine |
constitutional medicine 200 C in sugar of milk twice in a week for a duration of 2 month |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Cases with dandruff with age of 15 to 55 years from both sexes will be selected
Subjects exhibiting mild to moderate flaking of scalp after clinical examination
Subjects having stopped any possible antidandruff treatment for at least 2 weeks
4. Patient willing to give written consent to participate study. |
|
| ExclusionCriteria |
| Details |
Cases with other serious illness carcinomas
Subjects who used topical treatment for scalp(anti dandruff,antihairloss) or
corticosteroid treatment during last 2 weeks before the start of the study
Continuous use of steroids.
Subjects with cutaneous affection of the scalp other than dandruff.(psoriasis,alopecia,pediculosis,atopic dermatitis) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical study
Title: Reduce ASFS score in patient affected with dandruff
Description: baseline ASFS score- ASFS score
Interval:3 months |
Changes in the baseline ASFS score and final ASFS score in 3 month duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of therapeutic effectiveness of Azadirachta indica and homoeopathic constitutional medicine among the group |
After 1 year after completion of study |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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 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
|
Clinical evaluation of antifungal effect of Azadirachta indica in patients with dandruff - A randomized clinical trial. Study will be of parallel group and the other group will receive homoeopathic constitutional medicine.
Diagnosis of the case and the evaluation of the study will be based on the estimation of ASFS score of the subject before and after the study. For clinical study ASFS score will be evaluated 1 month interval . Obtained values will be taken
for analysis. Outcome will be measured by the reduction in the ASFS score in all
cases. Here am doing only clinical evaluation of azadirachta indica in patients with dandruff by using ASFS score . |