| CTRI Number |
CTRI/2025/10/096028 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
To Study the ffectiveness of Individualized Homoeopathic Medicine in Fifty Millesimal Potency in the Management of Allergic Rhinitis Among Adults |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicine in Fifty Millesimal Potency in the Management of Allergic Rhinitis Among Adults an Experimental Non Controlled Study |
| Trial Acronym |
Allergic Rhinitis With Fifty Millesimal |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejal Kailas Tagwale |
| Designation |
PG Student |
| Affiliation |
Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital |
| Address |
Dr G D Pol Foundation Y M T Homoeopathic Medical College and P G Institute Hospital, Institutional Area, Sector 04, Kharghar, Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
9172608944 |
| Fax |
|
| Email |
tejaltagwale@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sameer B Pol |
| Designation |
PG Guide HOD And Professor |
| Affiliation |
Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital |
| Address |
DR G D POL FOUNDATION Y M T HOMOEOPATHIC MEDICAL COLLEGE AND P G INSTITUTE HOSPITAL INSTITUTIONAL AREA SECTOR 04 KHARGHAR NAVI MUMBAI
Raigarh MAHARASHTRA 410210 India |
| Phone |
9773597900 |
| Fax |
|
| Email |
sampol98@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sameer B Pol |
| Designation |
PG Guide HOD And Professor |
| Affiliation |
Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital |
| Address |
DR G D POL FOUNDATION Y M T HOMOEOPATHIC MEDICAL COLLEGE AND P G INSTITUTE HOSPITAL INSTITUTIONAL AREA SECTOR 04 KHARGHAR NAVI MUMBAI
Raigarh MAHARASHTRA 410210 India |
| Phone |
9773597900 |
| Fax |
|
| Email |
sampol98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol Foundation Y M T Homoeopathic Medical College and P G Institute Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Tejal Kailas Tagwale |
| Address |
Dr G D Pol Foundation Y M T Homoeopathic Medical College and P G Institute Hospital, Institutional Area, Sector 04, Kharghar, Navi Mumbai |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 Tejal Kailas Tagwale |
Dr G D Pol Foundation Y M T Homoeopathic Medical College Kharghar Navi Mumbai |
Dr G D Pol Foundation Y M T Homoeopathic Medical College and P G Institute Hospital, Institutional Area, Sector 04, Kharghar, Navi Mumbai,Taluka Panvel, District Raigarh, State Maharashtra, Country India PIN Code 410210 Raigarh MAHARASHTRA |
9172608944
tejaltagwale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital |
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 management |
Homoeopathic management with individualized homoeopathic medicine in fifty millesimal potency.Total Duration of Study is 18 months.Each case will be studied for period of 6 Months or if remission occurs whichever is earlier. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give consent for the study.
Clinically diagnosed cases of allergic rhinitis.
Patients of all genders.
Patient of adult age group.
|
|
| ExclusionCriteria |
| Details |
Patients with complications of allergic rhinitis like asthma, hyperpyrexia.
patient taken any line of treatment in the past 1 month or during study.
Pregnant and lactating women.
Patients with suspected immuno-compromised disease.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome assessment will be done by applying mini rhinoconjunctivitis quality of life questionnaire
Minirqlq consist of five domains with a total of 14 questions
2 questions for practical problems
3 questions each for activity limitations nose eye and other symptoms
score indicating from 0 to 6 for each question
0 not troubled
1 rarely troubled
2 somewhat troubled
3 moderately troubled
4 quite a bit troubled
5 very troubled
6 extremely troubled
Total score for allergic rhinitis calculated by total mean of all 5 domains of minirqlq
Improvement will be calculated on the basis of total score of all 5 domains
Improved after total score lower than before baseline
Not improved no change in total score before baseline and after treatment
Worse after total score is higher than before baseline treatment
|
Duration of study is 18 months.
Duration of each case is each case will be studied for 6 months or till remission occur, whichever is earlier.
Duration of follow up is each case will be followed up on every 15th day or as required.
Clinical assessment will be done at baseline, 3rd month and at the end of treatment or at 6th month whichever is earlier
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2025 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Allergic Rhinitis is an inflammatory disorder of the nasal mucosa induced by allergen exposure triggering igE mediated inflammation clinically, it is characterized by four major symptoms- rhinorrhea, sneezing, nasal itching and nasal congetion, also ocular symptoms such as itching redness and tearing. Some plant have long lasting pollination, some patients allergic to perennial allergens have symptoms only for short periods, the pollination season is highly variable among the different countries, there is a high percentage of polysensitized patients, an allergic inflammation can be present even in absence of symptoms the so called minimal persistent inflammation. Rationale of the study Quality of Life is often impaired in patient with Allergic Rhinitis, due to the classic symptoms of the disease sneezing, pruritus, rhinorrhea and nasal obstruction. In the addition, the pathophysiology of Allergic Rhinitis often disrupts sleep, leading to irritability. A total burden of the disease goes beyond impairment of physical and social functioning. Allergic Rhinitis a chronic condition that affects adult, adolescents and children-is often undiagnosed or inadequately treated. Conventional treatment is Avoiding Allergens, Antihistamines, Corticosteroids and nasal decongestant Continuous use of topical nasal decongestants should be avoided to prevent rhinitis medicamentosa. Allergen causes allergic reactions in hypersensitive individuals like is Allergic Rhinitis.Homoeopathy is based on the principle of similia similibus curentur So homoeopathy materia medica has many medicine which produce Allergic Rhinitis like symptoms we can think of homoeopathic medicine in cases of Allergic Rhinitis for betterment of patient. Hence, the study is undertaking Effectiveness of Individualized Homoeopathic Medicine in Fifty Millesimal Potency in the management of Allergic Rhinitis Among Adults. Epidemiology studies suggests that 20 to 30 percent of adults affected with AR. Around 20 to 30 percent of Indian population suffer from Allergic Rhinitis and that 15 percent develops asthma. Existing knowledge gaps and how to bridge gaps Hahnemann faced various problems when he started practice with medicines prepared according to centesimal scale of potency. Lack of evaluating the effectiveness of individualized homoeopathic medicine in fifty millesimal potency for allergic rhinitis in adults. Most studies focus on centesimal potencies, with limited research on LM potencies and their impact on quality of life. Individualized Homoeopathic remedy is able to annihilate the disease and helps to reduce the intensity and frequency of the episode of Allergic Rhinitis and there was no side effect during and after the treatment. There is a better scope in homeopathy for treatment of Allergic Rhinitis since the treatment is based on Holistic and individualistic approach.addressing existing knowledge gap the further proving and verification are required. Dr. Hahnemann in 6th edition of organon given about that difficulties are wholly solved by my new, altered but perfect method. Aph 161 mentioned about renewed Dynamization. Aph.246 According to Fifty Millesimal scale are much more dynamic and in action also much more gentle, curative and rapid. So to bridge such existing knowledge gaps hence, the study is undertaking Effectiveness of Individualized Homoeopathic Medicine in Fifty Millesimal Potency in Allergic Rhinitis Among Adults. Definition A symptomatic disorder of nose induced by igE Mediated inflammation after allergen exposure. Primary Objective To study the Effectiveness of Individualized Homoeopathic Medicine In fifty millesimal potency in the management of allergic rhinitis among adults, up to 6 months or if remission occurs whichever is earlier. Other objective to assess the quality of life of allergic rhinitis patient among adults pre and post treatment scores on the basis of pre validated mini rhinoconjunctivitis quality of life questionnaire, up to 6 months or if remission occurs whichever is earlier Type of study design non-controlled experimental study. Setting location of study cases will be collected from outpatient department of the institute. Study population is clinically diagnosed cases of allergic rhinitis Withdrawal criteria Patients not coming for regular follow up. Patient who withdraw their consent from the study. Any exclusion criteria develops during study. Sampling technique is non probability purposive sampling. methods for data collection relevant to objectives informed and written consent will be taken from the patient Before taking each case. Non- probability purposive sampling will be done. Homoeopathic case taking will be done as per the proforma for collecting and analyzing data prepared. 36 cases of allergic rhinitis will be enrolled from the outpatient department of the institute.patient will be given individualized homoeopathic medicine in fifty millesimal as per the indication. Posology will be selected from fifty millesimal scale as per the requirement of the case. |