| CTRI Number |
CTRI/2024/03/064631 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of urticaria |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving the quality of life in adults with chronic spontaneous urticaria |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-0989 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reshmiara Khatun |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, OPD room no. PG2(Materia Medica),room no. 1 (Skin & Medicine), 12, Gobinda Khatick Road, Tangra,
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831092793 |
| Fax |
|
| Email |
reshmiarakhatun3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpita Basu |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, OPD room no. PG2(Materia Medica),room no. 1 (Skin & Medicine), 12, Gobinda Khatick Road, Tangra,
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpita Basu |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, OPD room no. PG2(Materia Medica),room no. 1 (Skin & Medicine), 12, Gobinda Khatick Road, Tangra,
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
| 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 Reshmiara Khatun |
D N De Homoeopathic Medical College and Hospital |
Department of Materia
Medica, OPD room no.
PG2 (Materia Medica),OPD room no 1 (Skin and Medicine), 12,
Gobinda Khatick Road,
Tangra
Kolkata
WEST BENGAL |
9831092793
reshmiarakhatun3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L501||Idiopathic urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will beprocured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients of both groups will receive concomitant care in the form of general management which will include pseudo-allergen-free (e.g., food additives), low-histamine (histamine rich food includes-sea food, fermented food like cheese, tomato, spinach, eggplant, avocado), and specific-food-free (e.g., sea fish) diets.The patients will be allowed conventional treatment anti-allergic medication as rescue remedies only to tackle any adverse events. Duration of treatment- 3 months. |
| Intervention |
Individualized Homoeopathic medicines in centesimal potencies plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in 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 teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and the sundry items will be procured. All the enrolled patients of both groups will receive concomitant care in the form of general management which will include pseudo-allergen-free (e.g., food additives), low-histamine (histamine rich food includes-sea food, fermented food like cheese, tomato, spinach, eggplant, avocado), and specific-food-free (e.g., sea fish) diets.The patients will be allowed conventional treatment anti-allergic medication as rescue remedies only to tackle any adverse events. Duration of treatment- 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of chronic urticaria diagnosed clinically. (EB00.1 is the ICD-11 code)
2.Patients having UAS7 score mild 7-15; moderate 16-27
3.Patients of either sex or transgenders.
4.Patients of the age between 18 and 65 years.
5.Participants having prior experience or knowledge of the treatment. E.g.- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
|
|
| ExclusionCriteria |
| Details |
1.Participation having UAS7 score: less than 7 and more than 27
2. Participation in a clinical trial within the last 3 months.
3. Non Providing written informed consent voluntarily.
4. Patients using regular conventional anti-allergic medication and/or glucocorticoid steroids.
5. Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
6. Patients having history of severe anaphylactic shock.
7. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
8. Pregnancy, puerperium, lactation.
9. Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
10.Self-reported immune-compromised state AIDS, Hepatitis &c.
11.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
|
|
|
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 |
| Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire |
Every month up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Urticaria Control Test (UCT) |
Every month up to 3 months |
| Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) |
Every month up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [reshmiarakhatun3@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
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. This double-blind, randomized (2:1), placebo-controlled trial will be conducted on 50 adults who are suffering from chronic spontaneous urticaria at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital, the efficacy of individualized homoeopathic medicines (IHMs) will be compared with identical looking placebos. Assessment will be done by Chronic Urticaria Quality of Life (CU-Q2oL questionnaire [Primary outcome], Urticaria Control Test (UCT), and MYMOP-2 [Secondary outcome] every month up to 3 months. Statistical analysis will be carried out to detect group differences. Results will be published in scientific journals. |