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CTRI Number  CTRI/2025/10/095915 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   To Study the Effectiveness of Homoeopathic Medicine in the Management of Acne Vulgaris Among Adults 
Scientific Title of Study   Effectiveness of Individualized Homoeopathic Medicine in Fifty Millesimal Potency in the Management of Acne Vulgaris Among Adults An Experimental Non Controlled 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 Yuvraj Shamrao Patgavkar 
Designation  PG Student 
Affiliation  Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital 
Address  Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital, Institutional Area, Sector 04, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9765909835  
Fax    
Email  ypatgavkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Sachin Y Chokakkar 
Designation  Guide And Professor 
Affiliation  Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital 
Address  Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital, Institutional Area, Sector 04, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9172488888  
Fax    
Email  newbeginingsach@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR Sachin Y Chokakkar 
Designation  Guide And Professor 
Affiliation  Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital 
Address  Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital, Institutional Area, Sector 04, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9172488888  
Fax    
Email  newbeginingsach@yahoo.com  
 
Source of Monetary or Material Support  
Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital, Institutional area, Sector 04, Kharghar, Navi mumbai, District Raigarh, State Maharashtra, Country India PIN Code 410210 
 
Primary Sponsor  
Name  Dr Yuvraj Shamrao Patgavkar 
Address  Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital, Institutional Area, Sector 04, Kharghar, Navi Mumbai, Taluka Panvel, District Raigarh, State Maharashtra, Country India PIN Code 410210 
Type of Sponsor  Other [SELF SPONSORED] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yuvraj Shamrao Patgavkar  Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute   Out Patient Department No.01, Medicine OPD,Ground Floor, Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital, Institutional Area, Sector 04, Kharghar, Navi Mumbai, Taluka Panvel, PIN code 410210
Raigarh
MAHARASHTRA 
9765909835

ypatgavkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic management  Homoeopathic management with individualized homoeopathic medicine in fifty millesimal potency. Total Duration of Study is 18 months. Each case will be studied for period of 6 months or if remission occurs whichever is earlier.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details 
Patients of adult age group.

Patients presented with acne vulgaris up to grade 3.

Patients of all genders.

Patient willing to give their free consent.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome assessment will be done by applying global acne grading system score.

The score for each area local score is calculated using formula
Local score is factor multiplied by grade 0 to 4
Highest grade present on that particular area will be considered as grade.
The global score is sum total of local score.

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

Outcome will be assessed in terms of following criteria
76 percent to 100 percent reduction of lesion is excellent improvement
51 percent to 75 percent reduction of lesion is significant improvement
26 percent to 50 percent reduction of lesion is moderate improvement
1 percent to 25 percent reduction of lesion is mild improvement
0 percent reduction of lesion is no change

 
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.
 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPICABLE  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   24/10/2025 
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)   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 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.

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

treatment.

5. 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.


 
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