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临床试验/CTRI/2025/10/095915
CTRI/2025/10/095915尚未招募不适用

Effectiveness of Individualized Homoeopathic Medicine in Fifty Millesimal Potency in the Management of Acne Vulgaris Among Adults An Experimental Non Controlled Study

Dr Yuvraj Shamrao Patgavkar1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年10月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Outcome assessment will be done by applying global acne grading system score.

研究概览

简要总结

Acne is chronic inflammation of pilosebaceous units. Acne vulgaris, also called Pimple in common man language. Acne vulgaris is a common skin disorder among adults, often resistant to conventional treatments and associated with side effects or relapse.

Homeopathy offers a holistic, individualized approach, and the fifty millesimal LM potency is known for its gentle yet deep action. However, there is limited clinical evidence on the effectiveness of individualized LM potency remedies specifically for acne vulgaris.

This study aims to explore the practical utility of this approach in a real world, noncontrolled setting to help fill this important gap in integrative dermatological care.

Definition

Acne Vulgaris is a Chronic inflammatory disease of pilosebaceous unit, manifesting generally in adolescence with pleomorphic lesion like comedones, papules, pustules, nodules, and cysts and extensive scarring can occur.

Epidemiology

It  generally starts during puberty and has been estimated to affect over 90 percent  of adolescents. The Global Prevalence of Acne Vulgaris is 20.5 percent. The comedo, which is primary lesion can be either closed whitehead or open blackhead.  Acne affects primarily the face, neck, upper trunk, and upper arms. On face acne occurs most frequently on cheeks and lesser degree on nose, forehead and chin. Acne is often first sign of increased sex hormone production.

Begins at the age of 8 to 12 years which is comedal in character. Women may experience a flair of papulopustular lesion about one week before menstruation. Acne may also begin in 20 to 35 year old women who have not experienced teenage acne. It occurs with greatest frequency between age 15 to 18 years in all genders.

As acne affects predominantly in adolescents and young adults it can have a negative effect on their self-esteem, mood and Quality of Life. Commonly embracement, anxiety, and leads to school avoidance or avoidance in appearing in public with lack of confidence and which rarely may lead to depression. Though it usually presents with less severity but may show long and deep psychological impact.

In conventional medicinal treatment of acne, patients with mild disease are treated topically with benzoyl peroxide, tretinoin, adapalene, or tazarotene, which n o r m a l i z e f o l l i c u l a r k e r a t i n i z a t i o n . The a d d i t i o n a l topical antibiotics helps control inflammatory papules and pustules. More significant disease treated with oral antibiotics for days. Another approach is oral contraception. Isotretinoin used for months is reserved for severe cystic disease because of its teratogenicity, possible associated risk of depression, and other significant side effects.

Homoeopathic management of any disease is wholistic approach to case of a disease. It is underpinned by the principle like cures like, where highly diluted substances are used for therapeutic purpose, by producing similar action to when substances used in healthy people. In Homoeopathy patient is considers as whole, Tissue changes comes in end of disease process. The Man is prior to organs, said by Dr. Kent means mind is first affected, and the tissue changes at physical level come very late in disease process. There are some medicine having their predominant action for Acne vulgaris but Dr. Hahnemann suggest constitutional individualized medicine for such chronic local affections.

Though available potencies in Homoeopathy improves chronic conditions and local affections, there are always complaints of relapsing, recurring of symptoms and aggravation of symptoms. To avoid this Dr. Hahnemann introduced new method of dynamization and he called it as Renewed Dynamization in aphorism 161 of 6th edition of Organon of Medicine. In order to obtain ideal cure, the dose of the medicine should be as small as just enough to stimulate vital force and to produce minimal medicinal aggravation. Master Hahnemann says, The suitableness of medicine for any given case of disease does not depend on its accurate homoeopathic selection of medicine alone, but likewise on proper size, or rather smallness of dose. Fifty Millesimal potency is highest potency and smallest dose in Homoeopathy. And repetition of such medicine frequently and for months does not cause aggravation as seen in centesimal potencies even in highest potency of centesimal with less frequent repetition. Hence, this study will be carried out, to explore the effectiveness of Individualized Homoeopathic Medicine with Fifty Millesimal potency in the Management of Acne Vulgaris among adults.

Primary Objective

To study the Effectiveness of Individualized Homoeopathic Medicine in Fifty millesimal potency in the Management of Acne Vulgaris among adults, up to 6 months or if remission occurs whichever is earlier.

Other objective

To assess the pre-treatment and post-treatment score in severity of Acne Vulgaris among adults on basis of Prevalidated  Global Acne Grading System Scale, up to 6 months or if remission occurs whichever is earlier.

Type of study design is  Non controlled Experimental study

Study setting  is  Cases will be collected from outpatient department of the institute.

Study population is Clinically diagnosed cases of Acne vulgaris.

Sampling technique is non probability purposive sampling.

methods of data collection relevant to objective

informed and written consent will be taken from the patient before taking each case.

non-probability purposive sampling will be done.

34 cases of acne vulgaris will be enrolled from the outpatient department of the institute.

Homoeopathic case taking will be done as per the proforma for collecting and analysing data prepared.

Patients will be given individualized homoeopathic medicine in fifty millesimal potency as per the indication.

posology will be selected from fifty millesimal scale as per the requirement of the case

Subject withdrawal criteria as follows

  1. Patient with irregular follow up.

  2. Patient who withdraws their consent from the study.

  3. If develops any other disease or complications during course

of treatment, requiring any medical or surgical intervention.

  1. Patient going from grade 3 to grade 4 during course of

treatment.

  1. Any exclusion criteria developing during study.

Despite the widespread use of individualized homeopathy in dermatology, there is a lack of robust experimental evidence on the efficacy of fifty millesimal  potency in managing acne vulgaris. Existing studies predominantly focus on centesimal potencies. Conventional treatments for acne, such as topical retinoids, antibiotics, and hormonal therapy, often pose challenges like antibiotic resistance, side effects, and relapse after discontinuation.

While LM potency is theorized to reduce initial aggravation and provide a gentler yet sustained therapeutic response, its clinical effectiveness in acne remains unexplored in a structured, quantitative manner.

There are very fewer prior researches which has systematically compared individualized Homoeopathic medicine in this  potency to conventional approaches using the Prevalidated Global Acne Grading System, leaving a critical gap in objective, reproducible outcome measurement. This study aims to bridge this gap by evaluating the role of LM potency in individualized homeopathic treatment for adult acne patients, offering potential insights into an alternative, patient-centric approach.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 64.00 Year(s)(—)
性别
All

入选标准

  • Patients of adult age group.
  • Patients presented with acne vulgaris up to grade
  • Patients of all genders.
  • Patient willing to give their free consent.

排除标准

  • Patients with suspected other immunocompromised disease.
  • Pregnant and lactating women.
  • Patient presenting with acne scars only.
  • Patients on any other line of treatment for Acne vulgaris or had taken any medication for acne in preceding 1 month.
  • Patients presenting with Acne conglobata, Acne fulminans, Hidradenitis suppurativa.

结局指标

主要结局

Outcome assessment will be done by applying global acne grading system score.

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

The score for each area local score is calculated using formula

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

Local score is factor multiplied by grade 0 to 4

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

Highest grade present on that particular area will be considered as grade.

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

The global score is sum total of local score.

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

The outcome assessment will be done on basis of pre and post treatment gags score

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

Outcome will be assessed in terms of following criteria

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

76 percent to 100 percent reduction of lesion is excellent improvement

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

51 percent to 75 percent reduction of lesion is significant improvement

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

26 percent to 50 percent reduction of lesion is moderate improvement

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

1 percent to 25 percent reduction of lesion is mild improvement

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

0 percent reduction of lesion is no change

时间窗: Duration of study is 18 months. | Duration of each case is each case will be studied for a period of 6 months or if remission occurs whichever is earlier. | Duration of follow up is each case will be followed up at the interval of 15 days or as and when required. | clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.

次要结局

  • NOT APPICABLE(NOT APPLICABLE)

研究者

发起方
Dr Yuvraj Shamrao Patgavkar
申办方类型
Other [SELF SPONSORED]
责任方
Principal Investigator
主要研究者

Dr Yuvraj Shamrao Patgavkar

Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital

研究点 (1)

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