| CTRI Number |
CTRI/2024/09/073597 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of acne with individualised homeopathic medicine |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicines in the treatment of Acne Vulgaris in adolescent age group: A Pre-Post Interventional Study. |
| 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 Jesika Sudha Tirkey |
| Designation |
Post graduate trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. |
| Address |
Mahesh Bhattacharyya homeomeopathic medical college and hospital. department of homeopathic Materia Medica, Dr B.N. Chakraborty sarani, Doomurjola, Howrah, West Bengal
Haora WEST BENGAL 711104 India |
| Phone |
9939235071 |
| Fax |
|
| Email |
jesikatirkey@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Baishakhi Ghosh |
| Designation |
Lecturer |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. |
| Address |
Mahesh Bhattacharyya Homoeopathic Medical college and Hospital, Department of Homeopathic Materia Medica
Dr B.N. Chakraborty sarani, Doomurjola, Howrah, West Bengal
Haora WEST BENGAL 711104 India |
| Phone |
8442992146 |
| Fax |
|
| Email |
drbaishakhibhatt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Baishakhi Ghosh |
| Designation |
Lecturer |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. |
| Address |
Mahesh Bhattacharyya Homeopathic Medical college and Hospital
Department of Homeopathic Materia Medica
Dr B.N. Chakraborty sarani, Doomurjola, Howrah, West Bengal
Haora WEST BENGAL 711104 India |
| Phone |
8442992146 |
| Fax |
|
| Email |
drbaishakhibhatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Jesika Sudha Tirkey |
| Address |
Dr B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal |
| 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 Jesika Sudha Tirkey |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. |
Department of Homeopathic Materia Medica, Dr B.N. Chakraborty, Doomurjola, Howrah-711104, West Bengal Haora WEST BENGAL |
9939235071
jesikatirkey11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional 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 |
Individualised Homeopathic Medicine |
All patients enrolled in the study will be receiving homoeopathic medicine on the basis of individualization. Both Centesimal and Fifty Millesimal potencies will be used. All medicine procured will be GMP certified. Along with medicines, the patients will receive dietary advice. Diet management according to individual patient’s requirements. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from acne vulgaris with eruptions like comedones (blackheads, whiteheads) papules, pustules, nodules, cysts.
Adolescent age group (10 years and 19 years)
Patients willing to give consent. |
|
| ExclusionCriteria |
| Details |
Any uncontrolled systemic or psychiatric diseases or life-threatening illness (e.g.,cancer, diabetes, epilepsy, severe asthma)
Pregnancy and lactation.
Self-reported immune-compromised state.
Subjects on hormonal contraceptives, steroids or non-steroidal anti-inflammatory drugs.
Patient Undergoing Homoeopathic treatment for any chronic disease within the last 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in terms of severity of acne will be assessed by GAGS(Global acne grading system) |
The patient will be asked for follow up on regular basis i.e. 4 weeks apart (or as per need of the patients) Each patient will get follow-up for at least 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| teenager quality of life index in age specific measure to access quality of life of teenager suffering from acne vulgaris. |
The patient will be asked for follow up on regular basis 4 weeks apart or as per need of the patient each patient will get follow up for at least 3 months. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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)?
|
Brief Summary
Modification(s)
|
INTRODUCTION: Acne vulgaris (AV) (ICD 11 ED80.Z) commonly known as acne is a chronic multifactorial disease of pilosebaceous follicle and characterised by comedones, papules, pustules, nodules, cysts and often scars remains. showing both inflammatory and non-inflammatory lesions.[3] There are numbers of descriptive terms applied to clinical variant of acne like Acne Conglobate, acne fulminans, acne excoriee, infantile acne. It is influenced by genetics, hormones, sebum production, and bacteria Cutibacteria acnes (formerly Propionibacterium acnes) Acne typically begins at puberty and often the first sign of increased sex hormone. It affects primarily the face, neck, upper trunk, upper arms. According to the Global Burden of Disease (GBD) study, Acne is estimated to affect 9.4% of the global population, making it the eighth most prevalent disease worldwide.The prevalence of acne among adolescents is about 80% worldwide in which adult acne affects 40% of the population. AV affects~85% of young adults aged 12–25 years.It is primarily the disease of adolescent, generally the involution of disease occurs before the age of 25, however there is great variability in onset and resolution occurs. About 12% of women and 3% of men will continue to have acne until age 44. Acne is also related some of the other diseased conditions where there is hyperandrogenic state and should be consider among women the presence of irregular menses, hirsutism, acanthosis nigricans, seborrhoea, or androgenic alopecia increases the likelihood of finding clinically significant hyperandrogenism. Such patients need to be investigated for androgen secreting pathology. Acne not only affect the person physically, but it also plays a very significant role in one’s cosmetic value as well, Patients experience psychological burdens like depression, anxiety, and low self-esteem because of acne. Acne can have a profound psychosocial impact, leading to decreased self-esteem, depression, and social withdrawal, particularly in cases of severe or scarring acne. The treatment of acne in modern medicine include a variety of topical and systemic agents, Topical treatment are Retinoids and antimicrobials such as benzoyl peroxide and antibiotics are the mainstay of topical acne therapy. Systemic treatment (e.g., oralantibiotics and hormonal therapy) Although not life-threatening, acne can have a significant adverse psychological and physical impact. And the treatment in homoeopathy which does not centred only on curing the patient at physical level but in mental sphere as well with a holistic approach. In homoeopathy we not only treat the disease but the person as whole regardless of name of disease. We focus on the outer manifestations of the disease and treat with the symptom similarity. homoeopathic philosophy allows treating the patients on the idea of individualisation. The totality of the symptoms includes subjective as well as objective understanding about the disease state where the underlying cause and individuals susceptibility are being put into consideration. JUSTIFICATION OF THE STUDY: Over the past few decades, the research and studies in homoeopathy has been centred more on the removal of acne at physical level but in this study, will also be focusing on psychological burden that the adolescents are facing with AV. A good amount of population of patients are visiting Mahesh Bhattacharya Homoeopathic Medical College & Hospital Howrah, with many of them suffering from Acne vulgaris and its consequences, they continue to suffer from acne vulgaris due to lack of proper health education, socio economic condition, and negligence. One study showed that there is a very high prevalence rate of acne vulgaris, among adolescent age group which is 80%. As having a very high prevalence, the studies done under this topic in homoeopathy is not sufficient. A through study available homoeopathic literature and exhaustive search has revealed that there are some studies have been done on Acne vulgaris, but the conclusion shows a non- significant effect favouring homeopathy against placebo and also most of the work is based on single homoeopathic medicine and there is paucity of exclusive work with a holistic approach on Individualized Homoeopathic Medicine(IHM) So, there is scope for working over it. The goal of this research with an intention to assess the effectiveness of IHM in treatment of Acne vulgaris as well as to scrutinize the impact on one’s psychology. RESEARCH QUESTION: Does individualized homoeopathic medicines have a significant role in treating patients with Acne vulgaris? Null Hypothesis (H0): There is no significant role of individualized homoeopathic medicines in treating patients with AV. Alternative Hypothesis (HA): Individualized homoeopathic medicine has significant role in treating the patients with AV. |