| CTRI Number |
CTRI/2023/09/057488 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Therapeutic and research] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in Acne vulgaris |
|
Scientific Title of Study
|
Role of Individualized Homoeopathic Medicine in 50 Millesimal Potencies in the Treatment of Acne Vulgaris: A Single Arm Pre-test Post-test Interventional Trial |
| 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 Swapan Paul |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Room No. 18, Dept. of Materia Medica, National Institute of Homoeopathy
Block - GE, Sector - III,
Salt Lake, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapan Paul |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Room No. 18, Dept. of Materia Medica, National Institute of Homoeopathy
Block - GE, Sector - III,
Salt Lake, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajib Purkait |
| Designation |
Research Associate |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Room No. 18, Dept. of Materia Medica, National Institute of Homoeopathy
Block - GE, Sector - III,
Salt Lake, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9748925539 |
| Fax |
|
| Email |
rajibpurkait20@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 |
| Dr Swapan Paul |
National Institute of Homoeopathy |
OPD No.18, Dept. of Materia Medica, National Institute of Homoeopathy
Block - GE, Sector - III, Salt Lake, Kolkata - 700106
North Twentyfour Parganas
WEST BENGAL |
9830148968
drspaul.2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Homoeopathy |
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 Homoeopathic Medicine |
Medicines will be selected according to the totality of symptoms. Homoeopathic medicines are known and safe for therapeutic uses. The medicines will be administered orally. The medicine will be prescribed in 50-millesimal potencies. Dose and repetition will be as per the homoeopathic principles.
Duration of therapy: 3 months |
| Comparator Agent |
Not applicable |
Not applicable, as it is a single arm study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i. Age:18 - 65 years.
ii. Gender: Both Male and Female.
iii. Diagnosed cases of Anal Fissure
iv. Patients using topical agents for fissure will be included after a washout period of two weeks, subject to persistence of symptoms and signs of fissures
v. Patient voluntarily giving written informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
i. Severe co-morbidities or any other uncontrolled systemic diseases, life-threatening illness etc. affecting Quality of Life.
ii. Pregnant or breast-feeding women.
iii. Substance abuse and/ or dependence.
iv. Psychologically unstable patients.
v. Previous history of surgical interventions for anal fissure.
vi. Diagnosed or any suspected cases of rectal malignancies
vii. Under-going homoeopathic treatment for any chronic diseases for last 3 months.
viii. Patients who are unable to read the patient information sheet and written consent form.
ix. Patient unwilling to take part in the study and not giving written consent for this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale (0-10) |
Baseline and after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes in scoring of HEMO-FISS scale
|
Baseline and after 3 months of treatment. |
| Modified Naranjo Criteria for Homoeopathy (MONARCH) |
After 3 months 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)
|
15/09/2023 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinisation, inflammation, and bacterial colonisation of hair follicles on the face, neck, chest, and back by Propioni bacterium acnes. Acne is estimated to affect 9.4% of the global population, making it the 8th most prevalent disease worldwide. From a homoeopathic perspective, skin diseases are the manifestations of an internal or constitutional disorder. Thus, the treatment of skin diseases is strictly based on constitutional criteria. Homoeopathy has produced few evidences in the treatment of Acne vulgaris. But the condition has not been researched yet using 50 millesimal potencies. Fifty millesimal potencies already having some evidences in treating acute or chronic diseases in its favour. Therefore, we shall undertake this study to explore the usefulness of individualized homoeopathic medicine in 50 millesimal potencies in the management of Acne vulgaris. In this study the homoeopathic medicines are administered orally, which are already known and safe for human use. all the patients will be prescribed individualized homoeopathic medicines in 50 millesimal potencies. Dosese and repetition will be as per homoeopathic principles. Outcomes will be Global Acne Grading System (GAGS) score, Dermatology Life Quality of Index (DLQI) score, measured at baseline and 3 months of treatment. The possible causal attribution will be evaluated by using Modified Naranjo Criteria for Homeopathy (MONARCH) Score, measured at the end of treatment in all cases (after 3 months of treatment). Duration of therapy: 3 months. |