| CTRI Number |
CTRI/2025/02/080480 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Homoeopathic medicine in Urticaria |
|
Scientific Title of Study
|
A clinical experimental study to ascertain the effectiveness of Homeopathic Medicine in cases of Urticaria assessed with UAS7 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 Niva Goti |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homeopathic Medical College, Parul University |
| Address |
Department of homeopathic materia medica, Rajkot Homeopathic Medical College, behind Jainath complex, Makkam Chowk, Gondal Road, Rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
|
| Fax |
|
| Email |
nivagoti14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sanja |
| Designation |
HOD/ Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of homeopathic materia medica, Rajkot Homeopathic Medical College, behind Jainath complex, Makkam Chowk, Gondal Road, Rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
9825885350 |
| Fax |
|
| Email |
rajesh.sanjarhmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Sanja |
| Designation |
HOD/ Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of homeopathic materia medica, Rajkot Homeopathic Medical College, behind Jainath complex, Makkam Chowk, Gondal Road, Rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
9825885350 |
| Fax |
|
| Email |
rajesh.sanjarhmc@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College attached with Sainath Hospital, Parul University, Rajkot, Gujarat, India 360002 |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College attached with Sainath Hospital Parul University |
| Address |
Behind Jainath complex, Makkam Chowk, Gondal Road, Rajkot, Gujarat 360002 |
| 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 Niva Goti |
Sainath Homoeopathic Hospital attached with Sainath Hospital, Rajkot, Gujarat, 360002 |
general OPD of Sainath Hospital, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot, Gujarat 360002
Rajkot
GUJARAT |
7201800627
nivagoti14@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: L509||Urticaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homeopathic Medicine |
Various Individualized Homeopathic medicine in 30, 200, 1m potency by Oral (sublingual) route at every week follow up for one week and study to be conducted for 9 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female are included.
18-50 years of age group are included.
Pre-diagnosed cases of urticaria.
New cases will be selected on basis of diagnostic criteria and definition of urticaria
|
|
| ExclusionCriteria |
| Details |
Age below 18 years and above 50 years are excluded
Patient having urticaria which is caused by autoimmune response.
Patient having urticaria with angioedema, Comorbidities, other skin disorder and anaphylaxis.
Patient who have taken other medication within last 1 month
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To understand the effectiveness of Homeopathic medicines in cases of urticaria. To study of
Sign & Symptoms of different homeopathic medicine related to urticaria. To assess the clinical utility of UAS7 score. |
this will be achieved within 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
For the effective assessment and evaluation,
disease intensity scores will also be
maintained according to UAS7 score |
this will be achieved within 9 months |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="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
|
THE MATERIAL UTILZED FOR THE STUDY : Informed consent i.e., to be signed by patient . A specialized designed case taking Performa (all the records, form and reports of the patient will be kept confidential.) . Suitable Materia Medica books, journals, articles, medicine and dermatology books, information from authentic online sites. The medication will be provided by dispensary of Sainath Homeopathic Hospital and obtained from authentic homeopathic pharmacy.
METHOD OF COLLECTION OF DATA : The study shall be performed in following ways: Type of study : Experimental, prospective study Method of sampling : Random sampling No of sample : 40 cases Duration of study : 09 months Selection of cases: randomly selection of cases based on criteria set by “Sainath Homeopathic Hospital “affiliated with Rajkot Homeopathic Medical College.
INTERVENTION GUIDELINE : Individualized Homoeopathic Medicine selection is based on the Totality of Symptoms for each cases their similimum is given to suitable patient. Potency, dose, and repetition are determined by the patient’s susceptibility.
CASE-TAKING PROCEDURE: Guidelines for case taking, as outlined by Dr. Hahnemann in aphorisms §83- §104. After proper analysis & evaluation of the symptoms of the case, Totality of symptoms will be formed.
SELECTION OF MEDICINE: Medicines will be selected with considering psychosomatic view point, after confirm with material medica and with help of repertory either manual or computer.
SELECTION OF POTENCY, DOSE AND REPETATION : Potency selection, dose and repetition are done according to principles laid down in Organon of Medicine.
ROUTE OF ADMINISTRATION OF MEDICINE : All medications will be administered orally.
FOLLOW UP AND MONITORING : Follow-up of each case will be taken at 7 days or as per requirement in acute exacerbation.
RECORDS : Record of Patient’s History, Report and Follow ups will be maintained as per standard procedure of institution.
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