| CTRI Number |
CTRI/2025/10/095556 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role Of Homoeopathic Medicine In Atopic Dermatitis |
|
Scientific Title of Study
|
To Evaluate The Role Of Individualized Homoeopathic Medicine In The Treatment Of Atopic Dermatitis A Randomized Control Trial |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravneet kaur |
| Designation |
PG scholar |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Sri Ganganagar |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Tantia University
Near Ricco Bus Stand Hanumangarh Road Sri Ganganagar Ganganagar Rajasthan
335002
Ganganagar RAJASTHAN 335002 India |
| Phone |
8837818207 |
| Fax |
|
| Email |
ravneet2620@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Deepak Sharma |
| Designation |
HOD Department Of Paediatrics |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Sri Ganganagar |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Tantia University
Near Ricco Bus Stand Hanumangarh Road Sri Ganganagar Ganganagar Rajasthan
335002
Ganganagar RAJASTHAN 335002 India |
| Phone |
8837818207 |
| Fax |
|
| Email |
responds@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ravneet kaur |
| Designation |
PG scholar |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Sri Ganganagar |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Tantia University
Near Ricco Bus Stand Hanumangarh Road Sri Ganganagar Ganganagar Rajasthan
335002
RAJASTHAN 335002 India |
| Phone |
8837818207 |
| Fax |
|
| Email |
ravneet2620@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Tantia University
Near Ricco Bus Stand Hanumangarh Road Sri Ganganagar Ganganagar Rajasthan
335002 |
|
|
Primary Sponsor
|
| Name |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Tantia University
Near Ricco Bus Stand Hanumangarh Road Sri Ganganagar Ganganagar Rajasthan
335002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ravneet Kaur |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute |
Room No. 102 Paediatrics Department
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute Tantia University
Near Ricco Bus Stand Hanumangarh Road Sri Ganganagar Ganganagar Rajasthan
335002 Ganganagar RAJASTHAN |
8837818207
ravneet2620@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
the dose and repetition of medicine max vary according to the susceptibility and sensitivity of patient. I this trial dosage and repetition will be as per the case and guidelines of organon of medicine
under the duration of 3 month |
| Comparator Agent |
Placebo |
The Patient will recieve placebo in homoeopathic globules |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of both sexes
2.Age 0-12 year
3.Patient’s parents willing to participate |
|
| ExclusionCriteria |
| Details |
1.Inability to follow the study protocol
2.Children with other skin disease that may complicate the atopic dermatitis
3.Children with chronic disease that may impact study outcome
4.Children or parent may adherent to study protocol |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in symptoms of atopic dermatitis such
as itching, redness, swelling, oozing in patient by receiving individualized
homoeopathic medicine |
before final exam of part 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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)
|
04/11/2025 |
| 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="0" 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
|
AIM:
To evaluate the efficacy of individualized homoeopathic medicine in the
treatment of atopic dermatitis.
OBJECTIVE: 1.To identify and evaluate common triggering factors responsible for atopic
dermatitis in children. 2. To study the miasmatic predominance of atopic dermatitis and its
homoeopathic approach. 3. To monitor changes in Scoring of atopic dermatitis (SCORAD) after giving
homoeopathic medicine
INTRODUCTION: Atopic dermatitis is an inflammatory non-communicable skin
disorder. The casual symptoms include itching, typical morphology, and occurrence
of rash, chronic relapsing pattern. Itching is the most commonly associated feature.
It is usually preceded by rash that might be severe, generally during night that is
followed by inflammatory red to brownish colored patches with small bumps. These
patches may exudate fluid and crust is formed over them when scratched. They may
occur wherever on the body, but they most commonly appear on the flexural
surfaces of the joints like inner sides of elbows, knees, and ankles. The skin is dry,
scaly with cracks on visual examination making it prone to environmental allergens.
There are few factors that worsen the presentation of dermatitis. Environmental
factors like staphylococcal skin infection, humidity, pollution, exposure to
detergents and stress plays crucial role as a precipitating factor. The etiology for
dermatitis is destruction of epidermal barrier destruction by immune system
12
disharmony as a result of gene environmental interaction. Stress is also a very
crucial factor in depression.
STUDY PROCEDURE: This clinical study aims to evaluate the effectiveness of individualized homeopathic treatment for atopic dermatitis, beginning with a target sample size of 96 participants. Each patient undergoes a thorough case-taking process, including detailed history, general physical examination, and specific assessment for atopic dermatitis, with diagnosis confirmed using ICD-10 criteria. Eligible patients are then randomized into two equal groups of 48 using a shuffled deck of cards—assigning even numbers to the treatment group and odd numbers to the control group. Baseline severity of atopic dermatitis is assessed using the SCORAD scale before initiating individualized homeopathic treatment for the treatment group. Participants are followed up at intervals of 15 days, 1 month, 2 months, and 3 months, with flexibility based on clinical condition. At the end of all follow-ups, SCORAD scoring is repeated to evaluate clinical improvement in both groups. The collected data is analyzed using appropriate statistical tools to interpret changes in scores, comparing the treatment group with the placebo group. Finally, the study concludes with the formulation of results and discussion based on the observed outcomes. |