| CTRI Number |
CTRI/2025/08/093481 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy for adult patient with hives and skin allergy |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of Individualised Homoeopathic Medicines in Adults with Chronic Spontaneous urticaria |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-1592 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Kumari Pandey |
| Designation |
Postgraduate trainee |
| Affiliation |
D.N.De Homoeopathic Medical college and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata-700046, West Bengal.
Kolkata
WEST BENGAL
700046
India |
| Phone |
9038341444 |
| Fax |
|
| Email |
drpoojapandey5982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Kumari Pandey |
| Designation |
Postgraduate trainee |
| Affiliation |
D.N.De Homoeopathic Medical college and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata-700046, West Bengal.
Kolkata
WEST BENGAL
700046
India |
| Phone |
9038341444 |
| Fax |
|
| Email |
drpoojapandey5982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhasish Ganguly |
| Designation |
Principal-in-charge, H.O.D. organon of medicine |
| Affiliation |
D.N.De Homoeopathic Medical college and Hospital |
| Address |
Department of Organon of medicine,Room no.-PG1, 12,Gobinda Khatick Road, Tangra,Kolkata-700046,West bengal,India
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, Govt of West Bengal.12, Gobinda Khatick Road, Kolkata, 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospita |
| Address |
12, Gobinda Khatick Road, Kolkata 700046 , West Bengal. |
| 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 Pooja Kumari Pandey |
D N De Homoeopathic Medical College and Hospital |
Department of Organon of Medicine, Skin and PG 1 OPD, 12 Gobinda Khatick Road, Tangra, Kolkata-700046, West Bengal.
Kolkata
WEST BENGAL |
09038341444
drpoojapandey5982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L50||Urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo plus Concomitant care |
This arm will receive placebo which is identical in appearance with verum, along with standard care. Each dose of placebo will consist of 3-4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on a clean tongue with an empty stomach; dosage and repetition depend upon the individual requirement of the cases.
Concomitant care (CC): All the enrolled patients will receive the following standard concomitant care, in accordance with established guidelines for the management of CSU.Patients will be advised for general lifestyle modifications -Wearing loose-fitting clothing to avoid pressure-induced aggravation of wheals and minimize discomfort,Avoidance of overheating and pressure, as these can provoke symptoms ,Avoid NSAIDs uptake as much as possible as it can worsen the disease,Stress management strategies will be advised, as emotional and psychological stress is a well-recognized exacerbating factor for CSU,Maintaining a consistent sleep routine,Ensuring adequate physical rest.
Dietary Advice:
All patients will receive individualized dietary guidance aimed at minimizing dietary triggers-Avoidance of pseudo-allergens (e.g., preservatives, food dyes, artificial additives) that may worsen CSU symptoms,Adoption of a low-histamine diet, especially avoiding histamine-rich foods such as fermented products, aged cheese, and alcohol.
Duration of therapy: 4 months. |
| Intervention |
Individualized homeopathic medicines plus Concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 3-4 globules (no. 40) of cane sugar, moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on a clean tongue in an empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing their teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion considering presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm.
Concomitant care (CC): All the enrolled patients will receive the following standard concomitant care, in accordance with established guidelines for the management of CSU.Patients will be advised for general lifestyle modifications -Wearing loose-fitting clothing to avoid pressure-induced aggravation of wheals and minimize discomfort,Avoidance of overheating and pressure, as these can provoke symptoms ,Avoid NSAIDs uptake as much as possible as it can worsen the disease,Stress management strategies will be advised, as emotional and psychological stress is a well-recognized exacerbating factor for CSU,Maintaining a consistent sleep routine,Ensuring adequate physical rest.
Dietary Advice:
All patients will receive individualized dietary guidance aimed at minimizing dietary triggers-Avoidance of pseudo-allergens (e.g., preservatives, food dyes, artificial additives) that may worsen CSU symptoms,Adoption of a low-histamine diet, especially avoiding histamine-rich foods such as fermented products, aged cheese, and alcohol.
Duration of therapy: 4 months.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases suffering from already diagnosed CSU (EB00.1 is the ICD-11 code) with UAS7 score: mild =7-15; moderate= 16-27
2.Age between 18 and 65 years.
3.Participants of either sex.
|
|
| ExclusionCriteria |
| Details |
1.Participant having UAS7 score: less than 7 and more than 27
2.Non- Providing written informed consent voluntarily.
3.Patients using regular conventional anti-allergic medication and/or glucocorticoid steroids.
4.Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
5.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic illness or life-threatening illness affecting quality of life or any organ failure.
6.Patient having a history of severe anaphylactic shock.
7.Pregnancy, puerperium, lactation.
8.Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
9.Immune-compromised state AIDS, Hepatitis &c.
10.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
11.Simultaneous participation in any other clinical trial
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the group differences in the Hives severity score (HSS) of adults with CSU at baseline and after 4 months of intervention. |
Baseline, and every week , upto 4 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Itch Severity Score (ISS) using UAS7 questionnaire |
Baseline, and every week , upto 4 months. |
| CU-Q2oL questionnaire |
Every month , upto 4 months. |
| Measure Yourself Medical Outcome-Profile version 2 (MYMOP-2) questionnaire |
Every month , upto 4 months. |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
05/09/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drpoojapandey5982@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Chronic Spontaneous Urticaria (CSU) is characterized by
persistent itchy hives and /or angioedema that recur for more
than 6 weeks and a duration of several years. Angioedema is
the rapid swelling of sub cutaneous, mucosa and submucosal
tissue that can appear anywhere on the body. In India,
between 15 and 20 percent of people develop urticaria at
some point in their lives. After adolescence, urticaria is more
common and twice as common in women as in men. Due
to its high prevalence and the possibility of severe allergic
reactions, including anaphylaxis in certain circumstances,
urticaria has become a significant worldwide health concern
in recent years. It affects strong negative influence on
patient’s well beings and health- related quality of life.
Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of
homoeopathic medicines in the treatment of CSU in adults.
A double-blind, randomized (2:1), placebo- controlled trial
will be conducted on 130 patients suffering from chronic
spontaneous urticaria at the outpatient department of D. N.
De Homoeopathic Medical College and Hospital.
Assessment will be done by the HIVE SEVERITY
SCORE (HSS) using UAS7
questionnaire as primary outcome and ISS (Itch Severity
Score), CU-Q2oL questionnaire and MYMOP (Measure Yourself Medical Outcome
Profile) as Secondary outcome, every month up to 4 months.
Comparative analysis will be carried out to detect group
differences between placebo and IHMs group . |