| CTRI Number |
CTRI/2026/03/106128 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic medicines in Chronic Urticaria |
|
Scientific Title of Study
|
ROLE OF INDIVIDUALISED HOMOEOPATHIC MEDICINES IN THE TREATMENT OF CHRONIC URTICARIA IN ADULTS: A SINGLE ARM PRE-POST ASSESSMENT INTERVENTIONAL STUDY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renu R |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD number 118, Department of Organon of Medicine, National Institute of Homoeopathy, Delhi, sector A-8, Chaudhary Ramdev Chowk, Narela, Delhi 110040
North
DELHI
110040
India |
| Phone |
7907152084 |
| Fax |
|
| Email |
renu.rajagopal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pritha Halder |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD number 118, Department of Organon of Medicine, National Institute of Homoeopathy, Delhi, Sector A-8, Chaudhary Ramdev Chowk, Narela, Delhi 110040
North
DELHI
110040
India |
| Phone |
9875547969 |
| Fax |
|
| Email |
drprithahalder@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pritha Halder |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD number 118, Department of Organon of Medicine, National Institute of Homoeopathy, Delhi, Sector A-8, Chaudhary Ramdev Chowk, Narela, Delhi 110040
North
DELHI
110040
India |
| Phone |
9875547969 |
| Fax |
|
| Email |
drprithahalder@gmail.com |
|
|
Source of Monetary or Material Support
|
| Renu R
OPD 118, National Institute of Homoeopathy, Sector A 8 Chaudhary Ramdev chowk, Narela Delhi 110040 |
|
|
Primary Sponsor
|
| Name |
Renu R |
| Address |
National Institute of Homoeopathy Sector A-8, Chaudhary Ramdev Chowk, Narela, Delhi 110040 |
| Type of Sponsor |
Other [self] |
|
|
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 Renu R |
National Institute of Homoeopathy, Delhi |
Organon of medicine, OPD no. 118 and 130 Sector A-8, Chaudhary Ramdev Chowk, Narela, Delhi 110040.
New Delhi
DELHI |
7907152084
renu.rajagopal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, National Institute of Homoeopathy, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic Urticaria |
| Patients |
(1) ICD-10 Condition: L508||Other urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine. |
Intervention is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the cases or condition. Each dose consists of 2 globules of number 40 size of cane sugar, medicated with a single drop of indicated medicine to be taken orally in empty stomach. The medicine will be dispensed from the National Institute of Homeopathy; Delhi pharmacy which is procured from the GMP certified company. Potency, Dosage and repetition depending upon the homoeopathic principles or upon the individual requirement of the cases. total duration of therapy: 3 months for each patient. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants having a clinical diagnosis of chronic urticaria [23], characterized by hives or wheals lasting for more than 6 weeks.
2.Age between 18-65 years.[2]
3.Patient’s taking antihistamines will be enrolled after one month of wash out period.
4.Participants of all gender, religion and socioeconomic status.
5.Participants giving written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Patients with other severe dermatological conditions, autoimmune diseases or significant co-morbidities.
2.Pregnant or lactating women.
3.Patients already undergoing homoeopathic treatment for any chronic disease for last 6 months.
4.Patients having any other uncontrolled systemic diseases and on allopathic medications and immunocompromised patients
5.Patients having any psychiatric illness.
6.Patients having any addictions and substance abuses.
7.Simultaneous participation in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing Urticarial activity score (UAS7) before and after treatment |
The patient will be recorded UAS7 scoring every week. The outcome will be evaluated at the baseline, and at the end of 3rd month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Urticaria Control Test (UCT) |
It will be done at baseline and at the end of third month.
|
| Modified Naranjo criteria for Homoeopathy |
At the end of the treatment (3rd month) |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 3 |
|
Date of First Enrollment (India)
|
23/03/2026 |
| 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="6"
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
|
Step 1: Screening of the patients. Step 2: Selection of the patients clinically diagnosed with chronic urticaria considering the inclusion criteria. Step 3: Detailed case taking of every patient according as per homoeopathic technique. Patient’s information recorded in standard case taking proforma used in National Institute of Homoeopathy, Delhi. Step 4: Relevant investigation procedure will be done as per need of the case and inclusion and exclusion criteria will be fulfilled. Outcome will be measured at definite interval. Scoring for urticaria using UAS7 and UCT scale will be done at baseline and end of third month and MONARCH scoring will be done at the end of the third month. Step 5: Repertorization will be done using software Hompath 11. Step 6: Final selection of medicine will be done in consultation with Materia medica. Step7: Potency, dose, and repetition of medicine will be decided according to homoeopathic principle. Step8: General management such as appropriate diet, regimen and proper lifestyle modification will be advised to each and every patient. Step 9: Monthly follow up will be done for at least 3 months. And outcome will be assessed at the end of three months. Step 10: Observing the response of patient through scoring for urticaria using UAS7 scale and UCT. Step 11: Data comparison Step 12: Data analysis Step 13: Inference |