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Clinical Trials/CTRI/2024/09/073597
CTRI/2024/09/073597RecruitingPhase 2

Effectiveness of Individualized Homoeopathic Medicines in the treatment of Acne Vulgaris in adolescent age group: A Pre-Post Interventional Study.

Dr Jesika Sudha Tirkey1 site in 1 country40 target enrollmentStarted: September 20, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Improvement in terms of severity of acne will be assessed by GAGS(Global acne grading system)

Study Overview

Brief Summary

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?

HYPOTHESIS:

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
10.00 Year(s) to 19.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Improvement in terms of severity of acne will be assessed by GAGS(Global acne grading system)

Time Frame: 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 Outcomes

  • 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.)

Investigators

Sponsor
Dr Jesika Sudha Tirkey
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Jesika Sudha Tirkey

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital.

Study Sites (1)

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