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CTRI Number  CTRI/2023/10/059150 [Registered on: 26/10/2023] Trial Registered Prospectively
Last Modified On: 23/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Homoeopathy in the Treatment of Nasal Allergy in Comparison with Allopathy 
Scientific Title of Study   Efficacy of Individualized Homoeopathy in the Treatment of Moderate to Severe Allergic Rhinitis in Comparison with Allopathy: A Multicentric, Randomized Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rompicherla GR Kiranmayee 
Designation  Research Officer (H), Scientist II  
Affiliation  Central Council for Research in Homoeopathy 
Address  Flat 102, Agranya Apartments, Visatat Enclave, North Kalyanpuri, Uppal, Hyderabad
Room No.9; CLinical Research Division, Regional Research Institute for Homoeopathy, OUB 32, Vikrampuri, Street No. 4, Habsiguda, Hyderabad
Medchal
TELANGANA
500007
India 
Phone  9030185002  
Fax    
Email  grkiranmayee85@ccrhindia.nic.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rompicherla GR Kiranmayee 
Designation  Research Officer (H), Scientist II  
Affiliation  Central Council for Research in Homoeopathy 
Address  Flat 102, Agranya Apartments, Visatat Enclave, North Kalyanpuri, Uppal, Hyderabad
Room No.9; CLinical Research Division, Regional Research Institute for Homoeopathy, OUB 32, Vikrampuri, Street No. 4, Habsiguda, Hyderabad

TELANGANA
500007
India 
Phone  9030185002  
Fax    
Email  grkiranmayee85@ccrhindia.nic.in  
 
Details of Contact Person
Public Query  
Name  Dr Rompicherla GR Kiranmayee 
Designation  Research Officer (H), Scientist II  
Affiliation  Central Council for Research in Homoeopathy 
Address  Flat 102, Agranya Apartments, Visatat Enclave, North Kalyanpuri, Uppal, Hyderabad
Room No.9; CLinical Research Division, Regional Research Institute for Homoeopathy, OUB 32, Vikrampuri, Street No. 4, Habsiguda, Hyderabad

TELANGANA
500007
India 
Phone  9030185002  
Fax    
Email  grkiranmayee85@ccrhindia.nic.in  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65 Institutional area Opp D block Janakpuri New Delhi 110058 
Type of Sponsor  Other [Autonomous Research Body under Ministry of AYUSH] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harpreet Kaur  Dr DP Rastogi Central Research Institute for Homoeopathy  A 1/1, Sector 24, Gautambudh Nagar, Noida - 201301
Gautam Buddha Nagar
UTTAR PRADESH 		 9810863650

Drharpreetmd@gmail.com 
Dr Xinix Xavier  National Homoeopathy Research Institute in Mental Health  NHRIMH, Sachivothamapuram, Kottayam - 68653
Kottayam
KERALA 		 7276597881

xinix.homoeopathy@gmail.com 
Dr Pooja Gautam  Regional Research Institute (Homoeopathy)  Ground Floor, Old Building of CARI (Ayurvedic Campus), Borsojai, P.O. Beltola, Guwahati
Karbi Anglong
ASSAM 		 9868534738

dr.poojagautam@gmail.com 
Dr Rompicherla GR Kiranmayee  Regional Research Institute (Homoeopathy)  OUB32, Vikrampuri, Habsiguda, street No.4, Hyderabad, Telangana
Medchal
TELANGANA 		 9030185002

grkiranmayee85@ccrhindia.nic.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Central Ethics Committee, CCRH  Approved 
Institutional Ethical Committee NHRIMH Kottayam  Approved 
Institutional Ethical Committee RRIH Guwahati  Approved 
Institutional Ethical Committee RRIH Hyderabad  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 
Comparator Agent  Allopathy  The prescription will be as per the advice and under supervision of the ENT Consultant. Active intervention will be for a period of initial 3 months followed by a period of 9 months of observation during which any acute exacerbations are treated with the intervention as per the initial allocation of the case and the number of such episodes will be noted. 
Intervention  HOMOEOPATHY  Based on the principles of homoeopathy, homoeopathic medicines in centesimal potencies will be prescribed. Active intervention will be for a period of initial 3 months followed by a period of 9 months of observation during which any acute exacerbations are treated with the intervention as per the initial allocation of the case and the number of such episodes will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with a history of an allergic cause and one or more of the following symptoms: episodic rhinorrhoea, sneezing, obstruction of the nasal passages with lachrymation, post-nasal discharge, and pruritus of the nasal mucosa, conjunctiva and oropharynx together with the anterior rhinoscopic findings of pinkish grey pale, boggy mucosa covered with a thin glistening mucous and hypertrophied turbinates.
Presence of moderate to severe symptoms as per ARIA classification and TNSS.
Voluntary written informed consent.
 
 
ExclusionCriteria 
Details  Patients who are not adequately symptomatic (Mild cases as per ARIA classification and TNSS) or have rhinoscopic findings not consistent with the diagnosis of AR
Patients with serious illnesses (known cases of severe renal or hepatic diseases, malignancy, etc.)
Patients under any medication for the symptoms of Allergic rhinitis in the past 15 days
Cases with other causes of chronic rhinitis or complications of AR like nasal polyposis, bacterial sinusitis, etc.,
Patients with significant psychological diseases
Pregnancy and lactation
Patients not ready to give informed consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in TNSS (Total Nasal Symptom Score)
Changes in RCAT (Rhinitis Control Assessment Test)  		 At Baseline and every 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the quality of life of the patient through RQLQ
Changes in rhinoscopy and AEC.
No. of exacerbations during 1 year follow-up period between the groups.
To evaluate the role of homoeopathic organopathic remedies in the management of acute exacerbations of Allergic rhinitis in the homoeopathic arm.
 		 Improvement in the quality of life of the patient through RQLQ every 3 months.
Changes in rhinoscopy and AEC at 6 months intervals.
No. of exacerbations during 1 year follow-up period between the groups.


 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   01/11/2023 
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="2"
Months="0"
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 - NO
Brief Summary  

The study is intended to evaluate the efficacy of individualized homoeopathic treatment compared with Allopathy in treating moderate to severe Allergic rhinitis over one year follow-up period. Further, the study also intends to evaluate the role of homoeopathic organopathic remedies like Allium cepa, Ambrosia artimisiaefolia, Aralia racemosa, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Kali iod, Naphthalinum, Pollantinum, Sabadilla, Sanguinaria nigra, Sinapis nigra, Skookum-chuk and Sticta pulmonaria in the management of acute exacerbations of Allergic rhinitis in the homoeopathic arm.

For analysis of the data, the intention-to-treat population is considered. The primary outcome parameters, TNSS, and RCAT scores will be analyzed using the Kruskal Wallis H Test. Other appropriate statistical tools will be used to analyze other variables. 
 
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