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
|
|
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
|
|
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. |