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CTRI Number  CTRI/2024/05/067618 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Natrum group of Homoeopathy in Acne Vulgaris 
Scientific Title of Study   A clinical study of Natrum group in cases of Acne Vulgaris by GAGS Scale 
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 Jyotiben Naranbhai Balas 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  8320007487  
Fax    
Email  jyoti.balas.jb24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Sanja 
Designation  Professor and HOD of Materia Medica 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9825885350  
Fax    
Email  rajesh.sanjarhmc@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Jyotiben Naranbhai Balas 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  8320007487  
Fax    
Email  jyoti.balas.jb24@gmail.com  
 
Source of Monetary or Material Support  
101, Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Behind jainath complex, Makkam chowk, Rajkot - 360002 Gujarat, India 
 
Primary Sponsor  
Name  Rajkot Homoeopathic Medical College 
Address  Rajkot Homoeopathic Medical College, Behind jainath complex, Makkam chowk, Rajkot - 360002 Gujarat, India 
Type of Sponsor  Private medical college 
 
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 Jyotiben Naranbhai Balas  Rajkot Homoeopathic Medical College  101, Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Behind jainath complex, Makkam chowk, Rajkot - 360002
Rajkot
GUJARAT 
8320007487

jyoti.balas.jb24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat  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 
Comparator Agent  NIL  NIL 
Intervention  Natrum group of Homoeopathic Medicines  Natrum group of Homoeopathic Medicines (e.g. nartum mur.,natrum ars., natrum carb., natrum phos., natrum sulph., etc.) Mode of Administration: Oral (sublingual) Selection of potency, Dose and Repetition: Natrum group of Medicines in 30, 200, 1M potency. Selection of Dosage, Potency and Repetition will be according to susceptibility of patient and principles of Organon of Medicine. The total duration of this intervention is 9 months. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients irrespective of their caste, religion and socio-economic condition. Pre-diagnosed cases of acne vulgaris or newly added cases having a diagnosis of Acne vulgaris. 
 
ExclusionCriteria 
Details  Patients having a age under 12 and more than 25 years will be excluded
Pregnant and lactating mother.
Patients with other systemic illness or serious pathological condition.
Patients complain complicated with other skin disease.
Patients with other acne types.
Patients taking other therapeutic measures for Acne vulgaris or any other disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
For the effective assessment and evaluation, disease intensity scores will also be
maintained according to GAGS- Score. 
After the intervention, the first follow-up will take place in 15 days, followed by subsequent follow-ups every 15 days. There will be some improvement after prescribing the Natrum group of Homoeopathic Medicines. 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical improvement - Disappearance or relief of symptoms, improvement in general health & reduction in area spread.  There will be some improvement after prescribing Natrum group of Homoeopathic Medicines, noticeable during the first follow-up after 15 days. 
 
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   N/A 
Date of First Enrollment (India)   31/05/2024 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back.
• The severity of this condition can vary, ranging from a mild presentation with only a few comedones to more severe forms characterized by disfiguring inflammatory manifestations, which can lead to hyperpigmentation, scarring, and adverse psychological effects.
• Acne is estimated to affect 9.4% of the global population, making it the eighth most prevalent disease worldwide.
• Acne is one of the most common skin disorders worldwide, with an estimated global prevalence of 9.38%. According to the Global Burden of Diseases (GBD) study, acne affects ~85% of young adults.
• However, there are instances where acne can persist into adulthood or even develop for the first-time during adulthood.
• Better understanding of factors affecting acne vulgaris may, therefore, serve to identify patients needing special attention.
• Acne tends to be chronic, and is obstinately resistant to treatment. Moreover, it is subjected to periods of aggravation without treatment of any kind. Available management in Allopathy includes topical agents; benzoyl peroxide, antibiotics, retinoids, etc. as the mainstay of treatment; these can be given in combinations. While systemic therapy includes oral antibiotics, hormonal therapy, and isotretinoin but have not much relief.
• The treatment comes with known side effect such as irritant dermatitis, development of bacterial resistance.
• In Homoeopathic Natrum group medicines emphasize individualization based on specific personality and emotional traits. This personalized approach could potentially address the underlying emotional and stress factors that may contribute to acne vulgaris, offering a more holistic treatment approach.
• Psychosomatic manifestation play a major role in acne like low self-esteem, social isolation and anxiety due to look consciousness.
 
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