| CTRI Number |
CTRI/2023/12/060827 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of individualized homoeopathic medicines in the treatment of Acne vulgaris: Double- blind, randomized, placebo-controlled trial |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines in the treatment of Acne vulgaris: Double- blind, randomized, placebo-controlled trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitin Kumar Saklani |
| Designation |
Research Officer (H)- Scientist 1 |
| Affiliation |
Central council for research In Homoeopathy |
| Address |
Room 1. General OPD. Regionnal Research Institute for Homoeopathy, Shimla.
C-5, Sector-2, New Shimla
Shimla
HIMACHAL PRADESH
171009
India |
| Phone |
08744021902 |
| Fax |
|
| Email |
ccrhnitinsaklani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Kumar Saklani |
| Designation |
Research Officer (H)- Scientist 1 |
| Affiliation |
Central council for research In Homoeopathy |
| Address |
Room No. 1, Regional Research Institute for Homoeopathy, Shimla
C-5, Lane no. 1, Main road, Sector-2, New shimla - 171009
Shimla
HIMACHAL PRADESH
171009
India |
| Phone |
08744021902 |
| Fax |
|
| Email |
ccrhnitinsaklani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Singh |
| Designation |
Research Officer (H)- Scientist 2 |
| Affiliation |
Central Council for Research In Homoeopathy |
| Address |
Technical department, Room no. 312, 61-65, Institutional area.
Jawahar lal Nehru Bhartiya chikitsa Avum Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opp-D- Block, Janakpuri, New Delhi- 110058.
West
DELHI
110058
India |
| Phone |
09818785593 |
| Fax |
|
| Email |
dr.deepti.2821@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for research in Homoeopathy (CCRH). |
|
|
Primary Sponsor
|
| Name |
Central council for research In Homoeopathy |
| Address |
Jawahar Lal Nehru Bharrtiya chikitsa Avum Homoeopathy Anusandhan Bhawan. 61-65, Institutional Area, Opp-D- Block, Janakpuri, New Delhi- 110058. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepti Singh |
Central Council for Research in Homeopathy. |
Technical department, Room no. 312, 61-65, Institutional Area, Janakpuri, New Delhi- 11058
South West
DELHI |
9818785593
dr.deepti.2821@gmail.com |
| Dr Shweta Gautam |
Dr, D P Rastogi Central Research Institute for Homoeopatlhy. |
Room No. 226, Dr D P Rastogi Central Research Insitute for Homoeopathy. A-1/ I, Sector- 24, Noida, Uttar Pradesh- 201301.
Gautam Buddha Nagar
UTTAR PRADESH |
9999566890
dr.shwetagtm@gmail.com |
| Dr Nitin Kumar Saklani |
Regional Research Institute for Homoeopathy, Shimla |
OPD No. 1, Regional Research Institute for Homoeopathy, Shimla, C-5, Lane no. 1, Main road, Sector-2, New shimla - 171009
Shimla
HIMACHAL PRADESH |
8744021902
ccrhnitinsaklani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathy |
Individualized homoeopathic medicine will be prescribed as per the totality of symptom.
For 4 months |
| Comparator Agent |
Placebo |
Identical placebo will be prescribed.
For 4 months |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written consent to undergo homoeopathic treatment.
Age range: 11-40 years.
Both sexes, all socio-economic status, all religions.
Those patients who have been diagnosed with acne vulgaris.
Patient willing to give written consent (Children between 11 to 15 years should give written consent in presence of parents).
|
|
| ExclusionCriteria |
| Details |
Patients suffering from life-threatening infections.
Cases already undergoing homoeopathic treatment elsewhere for other chronic disease.
Patients having Substance abuse and/ or dependence.
Patient below 11 years and above 40 years.
Patient suffering from other underlying deep dyscrasias like PCOS etc. which is responsible for Acne vulgaris.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Acne Grading Score (GAGS) |
Fortnightly till 4month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiff Acne disability index (CADI) |
Fortnightly till 4month. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/01/2024 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Title: "Effectiveness of Individualized Homoeopathic Medicines in the Treatment of Acne Vulgaris: A Double-Blind, Randomized, Placebo-Controlled Trial"
Abstract:
Objective: This double-blind, randomized, placebo-controlled trial aims to investigate the effectiveness of individualized homoeopathic medicines in the treatment of Acne Vulgaris.
Methods: A cohort of 120 individuals diagnosed with Acne Vulgaris will be randomly assigned to either the intervention group receiving individualized homoeopathic medicines or the control group receiving a placebo. The randomization will be performed using computer-generated random numbers. Both groups will be subjected to identical double-blind procedures, ensuring that neither the participants nor the investigators are aware of the treatment allocation.
Intervention: Participants in the intervention group will receive individualized homoeopathic medicines tailored to their specific symptoms and constitution. The selection of homoeopathic remedies will be based on a thorough individualized assessment conducted by experienced homoeopathic practitioners. The control group will receive a placebo with similar appearance and taste.
Outcome Measures: The primary outcome measure will be the reduction in GAGS score (Global Acne Grading system). Secondary outcome measures will include CADI score and photographic improvement.
Keywords: Acne Vulgaris, Homoeopathic Medicines, Individualized Treatment, Double-Blind, Randomized Controlled Trial, Placebo. |