| CTRI Number |
CTRI/2024/12/078577 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicine in the management of Atopic Dermatitis |
|
Scientific Title of Study
|
A clinical study to verify Hering’s Law of Cure in the management of Atopic Dermatitis using individualised Homoeopathic Treatment |
| 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 SHABNAM REHMAN |
| Designation |
JUNIOR RESIDENT(DEPARTMENT OF HOMOEOPATHIC PHILOSOPHY) |
| Affiliation |
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF HOMOEOPATHIC PHILOSOPHY,ROOM NO-110,NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,B-BLOCK,DEFENCE COLONY,NEW DELHI
South
DELHI
110024
India |
| Phone |
9999560253 |
| Fax |
|
| Email |
nocturnal.rehman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BIPIN JETHANI |
| Designation |
HOD ( HOMOEOPATHIC PHILOSOPHY) |
| Affiliation |
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF HOMOEOPATHIC PHILOSOPHY,NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, B- BLOCK, DEFENCE COLONY,NEW DELHI
South
DELHI
110024
India |
| Phone |
9810146343 |
| Fax |
|
| Email |
drbipin.jethani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHABNAM REHMAN |
| Designation |
JUNIOR RESIDENT (DEPARTMENT OF HOMOEOPATHIC PHILOSOPHY) |
| Affiliation |
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF HOMOEOPATHIC PHILOSOPHY, ROOM NO-110, NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,B-BLOCK,DEFENCE COLONY,New Delhi
South
DELHI
110024
India |
| Phone |
9999560253 |
| Fax |
|
| Email |
nocturnal.rehman@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD Of Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony,New Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital,B- BLOCK,Defence Colony New Delhi-110024 |
| Type of Sponsor |
Government 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 SHABNAM REHMAN |
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF HOMOEOPATHIC PHILOSOPHY, ROOM NO-110, NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,B-BLOCK,DEFENCE COLONY,NEW DELHI-110024
South
DELHI |
9999560253
nocturnal.rehman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of Nehru Homoeopathic Medical College and Hospital iCOMMITEE OF NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
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 |
administration of individualized homoeopathic medicine |
After screening and obtaining consent using specified selection (inclusion and exclusion) criteria, 30 eligible patients will be included in the trial. Following that patient will be planned to receive individualized homoeopathic remedy. Individualized dose will be selected on the judgement of susceptibility of the patients. Subsequent prescription will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. All medicines will be procured from good manufacturing practice(GMP) certified firm .Selection of potency, dosage and mode of administration will be based upon the severity of symptoms, susceptibility of the patient, miasmatic background. Mode of administration will be oral. Depending upon the severity of symptoms, reaction of patient and susceptibility of patient, repetition of remedy will be done. Follow up will depend upon the necessity and severity of the case. Preferably once every week for a month and then after 15 days |
| Comparator Agent |
N/A
|
N/A |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who satisfy Hanifin and Rajka’s criteria for atopic dermatitis
2.Subjects of both sexes of age group 4-60 yrs |
|
| ExclusionCriteria |
| Details |
1.Patients who are too sick for consultation, unable to read patient information sheets,unwilling to take part or not giving consent to join the study(self or by guardian)
2.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
3.Pregnant women and lactating mothers.
4.Substance abuse and/or dependence. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SCORAD INDEX
DLQI |
Once every week for a month and then after every 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MONARCH |
Once at baseline and then at the end of the study(1 year) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/01/2025 |
| 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 Applicable |
| 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
|
Research question: Does individualized Homoeopathic treatment effectively manage Atopic Dermatitis and does the progression of symptom resolution follow Hering’s Law of Cure? Hypothesis: Null hypothesis (H0): Individualized homoeopathic treatment does not result in significant improvement in the symptoms of Atopic Dermatitis and the progression of symptom resolution do not align with Hering’s Law of Cure. Alternative hypothesis (HA): Individualized homoeopathic treatment results in significant improvement in the symptoms of Atopic Dermatitis and the progression of symptom resolution aligns with Hering’s Law of Cure. AIM A clinical study to verify Hering’s Law of Cure in the management of atopic dermatitis using individualized homoeopathic treatment. OBJECTIVES: 1.To determine the improvement in the severity and extent of Atopic Dermatitis after individualized homoeopathic treatment as assessed by SCORAD INDEX score. 2.To assess improvement in quality of life using DLQI. 3.To verify if the progression of symptom resolution aligns with Hering’s Laws |