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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  
Name  Address 
None  Nil 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drdebanjan93@gmail.com].

  6. 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.

  7. 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.

 
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