Effectiveness of Individualized Homoeopathic Medicine in Fifty Millesimal Potency in the Management of Allergic Rhinitis Among Adults an Experimental Non Controlled Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Tejal Kailas Tagwale
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Outcome assessment will be done by applying mini rhinoconjunctivitis quality of life questionnaire
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 64.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient willing to give consent for the study.
- •Clinically diagnosed cases of allergic rhinitis.
- •Patients of all genders.
- •Patient of adult age group.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Outcome assessment will be done by applying mini rhinoconjunctivitis quality of life questionnaire
Time Frame: 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
Minirqlq consist of five domains with a total of 14 questions
Time Frame: 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
2 questions for practical problems
Time Frame: 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
3 questions each for activity limitations nose eye and other symptoms
Time Frame: 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
score indicating from 0 to 6 for each question
Time Frame: 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
0 not troubled
Time Frame: 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
1 rarely troubled
Time Frame: 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
2 somewhat troubled
Time Frame: 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
3 moderately troubled
Time Frame: 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
4 quite a bit troubled
Time Frame: 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
5 very troubled
Time Frame: 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
6 extremely troubled
Time Frame: 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
Total score for allergic rhinitis calculated by total mean of all 5 domains of minirqlq
Time Frame: 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
Improvement will be calculated on the basis of total score of all 5 domains
Time Frame: 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
Improved after total score lower than before baseline
Time Frame: 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
Not improved no change in total score before baseline and after treatment
Time Frame: 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
Worse after total score is higher than before baseline treatment
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Dr Tejal Kailas Tagwale
Dr G D Pol Foundation Y M T Homoeopathic Medical College And P G Institute Hospital