| CTRI Number |
CTRI/2024/10/074811 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of dandruff reducing effect of Homoeopathic drug Azadirachta indica under laboratory setting with clinical evaluation of the same in dandruff patients |
|
Scientific Title of Study
|
A randomised controlled trial to assess antifungal activity of Homoeopathic medicine Azadirachta indica against Pityrosporum ovale in patients with dandruff |
| Trial Acronym |
|
|
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 |
| 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
Gov Homoeopathic medical college Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9249337799 |
| Fax |
|
| Email |
drmansooralikr@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 |
| Phone |
7012044900 |
| Fax |
|
| Email |
raazna6797@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gov Homoeopathic medical college kozhikode pin 673010 kerala india |
|
|
Primary Sponsor
|
| Name |
Dr Rasina farsath K P |
| Address |
Department of homoeopathic repertory and case taking
Gov Homoeopathic medical college Karaparamba Kozhikode pin 673010 kerala india |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| patients |
gov Homoeopathic medical college calicut |
|
|
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 pin 673010 kerala india |
Room no 01 Specilised OPD skin and cosmetology op new building , dept of homoeopathic repertory and case taking, Government Homoeopathic Medical College, Karaparamba
p.o., Kozhikode, pin 673010 Kerala,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: L210||Seborrhea capitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Azadirachta indica |
Azadirachta indica 200 in 40
size globules 3 globules twice a day for 4 weeks orally |
| Comparator Agent |
costitutional medicine |
constitutional medicine given orally according to homoeopathic principle in 200 potency once in a week |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Cases with dandruff with age of 15 to 55 years from both sexes will be selected
2 Subjects exhibiting mild to moderate flaking of scalp after clinical examination
3 Subjects having stopped any possible antidandruff treatment for at least 2 weeks
4 Patient willing to give written consent to participate study |
|
| ExclusionCriteria |
| Details |
1 Cases with other serious illness carcinomas
2 Subjects who used topical treatment for scalp or
corticosteroid treatment during last 2 weeks before the start of the study
3 Continuous use of steroids
4 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 |
Comparative study
Title: Reduce ASFS score in patient affected with dandruff
Description: baseline ASFS score- ASFS score
Interval:6 months |
After medicinal prescription according to homoeopathic principle ASFS score
will be repeated in
3 month . Obtained values will be taken for analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of Therapeutic effectiveness of
Azadirachta indica & Constitutional medicine among the group |
After 1 Year (after completion of the 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 3 |
|
Date of First Enrollment (India)
|
18/10/2024 |
| 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
|
An in vivo study a randomised controlled clinical trial of antifungal activity of Azadirachta indica and costitutional medicine in dandruff patients .there will be two groups ,one group will receive medicine Azadirachta indica and other group will receive constitutional medicine . Diagnosis of the case and the evaluation of the study will be based on the estimation of ASFS score subject before and after the study. Obtained values will be taken for analysis. Outcome will be measured by the reduction in ASFS score in all case. |