| CTRI Number |
CTRI/2020/10/028623 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of allergic runny nose and sneezing |
|
Scientific Title of Study
|
Double-blind, randomized, placebo-controlled, pilot trial of individualized homoeopathic medicines in perennial allergic rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1259-4463 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debanjan Chowdhury |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine; OPD room no 12; 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata WEST BENGAL 700009 India |
| Phone |
7866864891 |
| Fax |
|
| Email |
drdebanjan93@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Rajat Chattopadhyay |
| Designation |
Principal |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine; OPD room no 12; 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata WEST BENGAL 700009 India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Rajat Chattopadhyay |
| Designation |
Principal |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine; OPD room no 12; 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata WEST BENGAL 700009 India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital,
265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, 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 |
| Debanjan Chowdhury |
The Calcutta Homoeopathic Medical College and Hospital |
Department of Practice of Medicine; OPD room no 12; 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal Kolkata WEST BENGAL |
7866864891
drdebanjan93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with 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 medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Route of administration: oral. Each patients will be given general advices on saline steam inhalations and acute homoeopathic remedies as rescue medication optionally, if and when required. But other medicines like antibiotics, glucocorticosteroids and antiallergics will not be permitted. Patients will be advised to be present for monthly follow-ups or more frequently if required. Food and drink containing vitamin C will be encouraged. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Route of administration: oral. Each patients will be given general advices on saline steam inhalations and acute homoeopathic remedies as rescue medication optionally, if and when required. But other medicines like antibiotics, glucocorticosteroids and antiallergics will not be permitted. Patients will be advised to be present for monthly follow-ups or more frequently if required. Food and drink containing vitamin C will be encouraged. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65 years and of either sex
2. Cases suffering from allergic rhinitis (2020 ICD-10-CM Diagnosis Code J30.89) – persistent and perennial variety and of moderate intensity for more than 1 year
3. Atopic: reactive to inhaled allergens
4. Literate patients; can read Bengali and/or English
5. Providing written informed consent to participate in the trial |
|
| ExclusionCriteria |
| Details |
1. Nasal abnormalities causing obstruction; e.g. nasal polyps, deviated septum
2. Allergen avoidance in past 6 weeks
3. Away from usual environment for more than 1 week during trial
4. Respiratory infections
5. Patients with risk of developing bronchial asthma
6. Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life
7. Patients who are too sick for consultation
8. Pregnant and puerperal women, and lactating mothers
9. Substance abuse and/or dependence
10. Self-reported immune-compromised state
11. Oral or parenteral steroids in past 6 months
12. Conventional desensitization in past 6 months
13. Previous homoeopathic immunotherapy for perennial AR
14. Undergoing homoeopathic treatment for any chronic disease within last 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Juniper Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ) |
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale (VAS) measures of nasal, non-nasal and global severity and quality of life (QoL) |
At baseline and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/10/2020 |
| Date of Study Completion (India) |
30/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet; to be published later |
|
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 [drdebanjan93@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2028?
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
Modification(s)
|
Perennial allergic rhinitis (PAR) is characterized by sneezing, rhinorrhoea, nasal stuffiness, and conjunctival, nasal, and pharyngeal itching and lacrimation, resulting from exposure to allergens throughout the year. An increasing prevalence of PAR has also been reported in India. Homeopathy is claimed to be beneficial in PAR, but evidence remains scarce. In this trial, the efficacy of individualized homeopathic medicines (IHMs) was compared against placebos in the treatment of PAR. This 3-month, double-blind, randomized (1:1), placebo-controlled trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, Kolkata with 60 participants with PAR. Each of the participants received either IHMs or identical-looking placebos, along with concomitant care. The primary outcome measure was Juniper’s rhino-conjunctivitis quality-of-life questionnaire (RQLQ); secondary outcome measures were visual analog scales (VAS) measuring symptom severities, all measured at baseline, and after 3 months. Group differences were calculated on the intention-to-treat sample. The significance level was set at p less than 0.05, two-tailed. Between-group differences in RQLQ total (mean difference: 29.5, 95% CI 18.9 to 40.0, p < 0.001), total nasal symptom severity VAS (mean difference 17.8, 95% CI 11.5 to 24.1, p < 0.001), non-nasal eye symptom VAS (mean difference: 9.3, 95% CI 1.0 to 17.7, p = 0.029), non-nasal mental symptom severity VAS (mean difference: 16.1, 95% CI 1.0 to 22.2, p < 0.001), global assessment VAS (mean difference: 20.5, 95% CI 14.2 to 26.9, p < 0.001), and QoL VAS (mean difference: 20.3, 95% CI 14.4 to 26.1, p < 0.001) were statistically significant favoring IHMs against placebos, with large effect sizes. Tuberculinum bovinum and Natrum muriaticum were the most frequently prescribed medicines. No serious adverse events were reported from either of the groups. Thus, IHMs performed significantly better than placebos in the treatment of PAR. |