| CTRI Number |
CTRI/2018/11/016248 [Registered on: 01/11/2018] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of pimples |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines in Treatment of Acne Vulgaris: Double Blind, Randomized, Placebo Controlled, Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1221-8164 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Rai |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Instittute of Homoeopathy |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD room no 5 & 7; Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
7565861275 |
| Fax |
|
| Email |
shu28d@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gobind Narayan Gupta |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD room no 5 & 7; Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9163197805 |
| Fax |
|
| Email |
dr.gn05gupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gobind Narayan Gupta |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD room no 5 & 7; Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9163197805 |
| Fax |
|
| Email |
dr.gn05gupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Homoeopathy; Block – GE, Sector – III, Salt Lake, Kolkata – 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
Block – GE, Sector – III, Salt Lake, Kolkata – 700106 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shruti Rai |
National Institute Of Homoeopathy |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD room no 5 & 7; Block – GE, Sector – III, Salt Lake, Kolkata – 700106
Kolkata
WEST BENGAL |
7565861275
shu28d@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 globules (no. 10) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP) certified firm. Along with medicines, the intervention arm will receive standardized guidelines for lifestyle modifications (LSM). Duration of therapy: 12 weeks. |
| Comparator Agent |
Placebo |
This arm, will receive placebo, indistinguishable from verum. Each dose of placebo shall consist of 6-8 globules (no. 10) of cane sugar, moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. This arm will also receive standardized LSM guidelines. Duration of therapy: 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from acne vulgaris
2. Both sexes
3. Age between 12 and 30 years
4. Patients giving written consent to participate
5. Literate patients who can read English and/or Bengali |
|
| ExclusionCriteria |
| Details |
1. Patients having severe form of acne vulgaris
2. Patients using oil based cosmetics for long period of time
3. Patients who are too sick for consultation
4. Unwilling to take part and not giving consent to join the study
5. Unable to read patient information sheet
6. Diagnosed cases of unstable mental or psychiatric illness
7. Uncontrolled or life threatening illness affecting quality of life or any organ failure
8. Pregnancy and lactation
9. Substance abuse and/or dependence
10. Self-reported immune compromised state
11. Undergoing homoeopathic treatment for any chronic disease within last 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Acne Grading System (GAGS) score |
At baseline and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiff Acne Disability Index (CADI) |
At baseline and after 12 weeks |
| Dermatology Life Quality Index (DLQI) |
At baseline and after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet, to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acne is estimated to affect 9.4% of the global population, making it the eighth most prevalent disease worldwide. Acne vulgaris gets itself enlisted with diseases that directly affect quality of life. Several studies showed significant result of homeopathic medicines as compared to the control group. In this prospective, double blind, randomised, placebo controlled, two parallel arms trial at National Institute of Homoeopathy, 126 patients suffering from acne vulgaris will be randomised in 1:1 ratio into either individualised homeopathic medicines or placebo. Global Acne Grading System (GAGS) score will be used as the primary outcome measure and Cardiff Acne Disability Index (CADI) questionnaire and Dermatological Life Quality Index (DLQI) as the secondary outcome measures; measured at baseline, after 12 weeks. At the end of 12 weeks, comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals. |