| 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
|
|
|
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
|
|
|
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. |