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CTRI Number  CTRI/2022/05/042495 [Registered on: 12/05/2022] Trial Registered Prospectively
Last Modified On: 11/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparative study of centesimal and millesimal potency in treatment of allergic rhinitis 
Scientific Title of Study   A Comparative Study on Homoeopathic Scale of Centesimal Potency and Millesimal Potency in the Treatment of Allergic Rhinitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chaithra CS 
Designation  PG Scholar 
Affiliation  Vinayaka Missions homoeopathic medical college and Hospital 
Address  Department of Organon OPD Room no 2e1 vinayaka missions homoeopathic medical College and hospital nh 47 sankari main road Seeragapadi tamilnadu Salem

Salem
TAMIL NADU
636308
India 
Phone  9496987541  
Fax    
Email  chaithrachithrasila@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr E Nisha Paul 
Designation  Professor and Head of Department 
Affiliation  Vinayaka Missions homoeopathic medical college and Hospital 
Address  Department of Organon OPD Room no 2e1 vinayaka missions homoeopathic medical College and hospital nh 47 sankari main road Seeragapadi tamilnadu Salem

Salem
TAMIL NADU
636308
India 
Phone  9995680275  
Fax    
Email  Nisha.gopal2012@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr E Nisha Paul 
Designation  Professor and Head of Department 
Affiliation  Vinayaka Missions homoeopathic medical college and Hospital 
Address  Department of Organon OPD Room no 2e1 vinayaka missions homoeopathic medical College and hospital nh 47 sankari main road Seeragapadi tamilnadu Salem

Salem
TAMIL NADU
636308
India 
Phone  9995680275  
Fax    
Email  Nisha.gopal2012@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Homoeopathic Medical College and Hospital nh47 Sankari main road Seeragapadi Salem Tamil nadu 
 
Primary Sponsor  
Name  Vinayaka Missions homoeopathic medical college and Hospital 
Address  nh 47 sankari main road seeragapadi salem Tamilnadu  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr E Nisha Paul  vinayaka missions homoeopathic medical college  Department of Organon OPD Room no 2e1 vinayaka missions homoeopathic medical College and hospital nh 47 sankari main road Seeragapadi
Salem
TAMIL NADU 
9995680275

Nisha.gopal2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College And Hospital Salem  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  Homoeopathic medicines  Homoeopathic medicines are selected on basis of symptom similarity and individualisation by using homoeopathic scale of millesimal and centesimal potency and the medicine is administered via orally and followup is taken in every 15 days and maximum period of study is 6 months 
Comparator Agent  Homoeopathic scale of centesimal and millesimal potency  homoeopathic medicines are selected on basis of symptom similarity and individualisation by using centesimal and millesimal potency and the medicine is administered orally and the follow up is taken in every 15 days maximum treatment period for patient under study is 6 months 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients selected from age 10 to 60 and patients with clinical presentation of allergic rhinitis 
 
ExclusionCriteria 
Details  cases with complications of allergic rhinitis and patients suffering from other systemic diseases and pregnant ladies will not be considered for the studies 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Absolute Eosinophil Count
Serum IgE level  
after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
it is expected that the proposed study will be useful in reducing the symptoms of Allergic Rhinitis and to improve the quality of life of the patients  after 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   15/05/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Allergic rhinitis is a very common disorder that affects up to 40% of the population. Allergic rhinitis is the most common type of chronic rhinitis, affecting 10 to 20% of the population,
and evidence suggests that the prevalence of the disorder is increasing. Severe allergic rhinitis has been associated with significant impairments in quality of life, sleep and work performance. According toWHO (2007), the global burden of allergic rhinitis was estimated to be 400 million and the prevalence among adult ranges between 10% and 32% in Asia Pacific region.
There are many researches conducted in the past to analyze the effectiveness of Homoeopathy in the treatment of Allergic Rhinitis, and was found that homoeopathic treatment is very much effective in treating allergic rhinitis. There by it improves the quality of life of patients. But mostly studies were done with specific remedies. So, this study is been taken to analyze the effectiveness of Millesimal and Centesimal potencies in the treatment of Allergic Rhinitis.
Hahnemann’s initial objective for working on the sixth edition of Organon of Medicine was his awareness of the ill effects caused by frequently repeated but not modified homoeopathic doses. He felt that the aggravations caused by centesimal potency increases the sufferings of the patient. Later from his
practice Hahnemann understood that, by administering liquid doses altered by succussions produces slight change
in potency and that this improves the therapeutic effect with less side effects. So, he introduced the concept of 50 millesimal potency or LM scale. In this potency, the strength of the medicine can be slightly increased every time by succussions. And the repetition and elevation in potency will not produce any aggravation or new unwanted symptoms in the patient.
 
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