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临床试验/CTRI/2025/10/095927
CTRI/2025/10/095927尚未招募3 期

Effectiveness of Boger's Philosophy in Homoeopathic Management of Allergic Rhinitis Among Adults : An Experimental Non - Controlled Study

Dr Riddhi Ladniya1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Outcome will be assessed in terms of-

研究概览

简要总结

Effectiveness of Bogers philosophy in homoeopathic management of allergic rhinitis among adults - an experimental non - controlled study

Background of Study- Boger’s Philosophy of forming totality which gives prior importance to pathological generals, ailments from, modalities  and time modalities will be considered in forming the individualised picture of a patient and then an appropriate remedy will be selected for treatment based on which further follow ups will be assessed to give better results and verify whether Bogers Philosophy is effective in treatment of Allergic Rhinitis.

Introduction –Allergic Rhinitis is a prevalent chronic condition characterized by nasal congestion, sneezing, rhinorrhea, and itching, significantly impacting quality of life. ***Despite the availability of various conventional treatments, recurrence and side effects remain common challenges.***Homoeopathy offers a holistic approach to managing allergic conditions, emphasizing individualized treatment based on symptom totality. The objective of this study is to reduce the prevalence of Allergic Rhinitis and to improve quality of life. Study of Bogers philosophy in cases of Allergic Rhinitis and framing the totality of symptom with the help of Bogers concept of totality and proper prescription of medicine to achieve cure in a more rapid and gentle way. Hence, this study is undertaken to understand the effectiveness of Boger’s philosophy in Homoeopathic management of Allergic Rhinitis.

Epidemiology

Allergic Rhinitis constitutes more than 50 percent of all allergies in India, and its incidence is steadily increasing worldwide. Surprisingly, it is more common in developed countries where the pollution is lesser in comparison to developing countries. Allergic Rhinitis and Asthma coexist frequently; in fact, Allergic Rhinitis appears first in about 45 percent of patients.Out of all non-communicable diseases, allergic diseases such as Allergic Rhinitis and asthma appear to have increased in India over the past decades. India is the home of nearly 20 percent of the global population with 1.35 billion people. Estimates of the prevalence of Allergic Rhinitis range from as low as 9 percent to as high as 42 percent. Approximately 22 percent of adolescents currently suffer from Allergic Rhinitis in India.

Here comes the role of Homoeopathy where the resistance of the patient is raised so that he will not remain allergic to a particular substance to which he was allergic before and he will not be susceptible to invading organisms. In Homoeopathy, the phrase Totality of Symptoms has been employed to denote the characteristic individual features of the case in developing the image of the patient. Dr. Bogers concept of totality formation is much more practical. His philosophy was running with Boenninghausens concept with stress on complete and physical general symptom. In his book Synoptic Key to Materia Medica, he has classified the symptomatology and valued accordingly.

This study bridges the gap by assessing the effectiveness of Boger’s Philosophy thus providing clinical evidence in the Homoeopathic Management of Allergic Rhinitis Among Adults.

Objectives

  1. To assess the effectiveness of Boger’s Philosophy in the Homoeopathic Management of Allergic Rhinitis.

  2. To compare pre treatment and post treatment Allergic Rhinitis Symptom Score ARSS in cases of Allergic Rhinitis.

  3. To study the Totality of Symptoms with Boger’s philosophy in cases of Allergic Rhinitis.

Methodology

  1. Type of study design A Non-Controlled Experimental Study.

  2. Study Setting Patients will be recruited from the Outpatient Department of the Institute.

  3. Duration of the Study: 18 months.

  4. Study Population Clinically diagnosed Patients of Perennial Allergic Rhinitis.

  5. Methods of selection of study subjects

i. Inclusion criteria

1.     Patients of Perennial Allergic Rhinitis.

2.     Patients of age group 20 to 40.

3.     Patients of all genders.

4.     Patients with controlled systemic comorbidities.

**ii.**Exclusion criteria

1.     Patients of Seasonal Allergic Rhinitis and Rhinoconjunctivitis.

2.     Patients of Perennial Allergic Rhinitis with associated Nasal and Respiratory disorders such as bronchial asthma, sinusitis respectively.

3.     Patients of Perennial Allergic Rhinitis with local comorbidities such as urticaria.

4.     Immuno-compromised patients.

5.     Pregnant or lactating women.

6.     Patients on any medication like Antihistamines/ Antibiotics, within 3 months prior to the study.

Subject withdrawal criteria

1.     Patients of Perennial Allergic Rhinitis with irregular follow-ups.

2.     Patients of Perennial Allergic Rhinitis who withdraw their consent from the study.

3.     Patients with Perennial Allergic Rhinitis who progress to Bronchial asthma.

4.     Patients of Perennial Allergic Rhinitis who take other medication during the study.

5.     Method of Selection of Comparison or Control GroupNot Applicable.

6.        Matching Criteria Not Applicable

7.        Operational definition

Allergic rhinitis is an inflammation of nasal airway triggered by allergens to which the affected individual has previously been sensitized.Allergic Rhinitis is characterized by sneezing, rhinorrhea, obstruction of the nasal passages, conjunctival, nasal and pharyngeal itching; and lachrymation.

Perennial Allergic Rhinitis – Affects patients throughout the year.

Bogers Philosophy

Dr. Bogers method of analysing symptoms is as follows

1. Modalities- Causation, time, temperature, weather, open air, posture, motion, eating and drinking, sleep, touch, discharges, etc.

2. Mind- Irritability, sadness, fear, placidity.

3. Sensations- Burning, Cramping, Cutting, Throbbing, etc.

4. Objective aspect- Restlessness, nervous excitability, facial expressions.

5. Part affected- Organs, side, right or left.

8****Specification of Instruments & Related Measurements

1.               Standardised Homoeopathic case-taking format.

2.               Nasal Examination.

3.               ARSS Scale will be filled using Interview method.

Allergic Rhinitis Symptom Score ARSS of Allergic Rhinitis will be applied to assess the severity before and after the treatment

OUTCOME ASSESSMENT CRITERIA

Severity of the Allergic Rhinitis symptoms will be quantified in terms of Allergic Rhinitis Symptom Score ARSS. Each symptom of Allergic Rhinitis will be assigned a numerical value and a total score will be measured at the base line. Data was recorded with proper care and base line score for each patient will be calculated as per the ARSS table given below.

Equation 1 and 2 are used to assess the improvement in Allergic Rhinitis symptoms among the patients.

Change in ARSS equals to Initial score minus Final Score                         1

Improvement equals to Change in ARSS divide by Initial Score multiply by 100          2

Change in ARSS value obtained from equation 1 will be used in equation 2 to assess the percentage improvement in symptoms of the patient.

Improvement in percentage

Improved or Not Improved

|100

Cured

|76 – 100

A marked improvement

|51 – 75

Moderate improvement

|26 – 50

Mild improvement

|Less than 25

Non-significant

|0

Worsening of symptoms

  1. Clinical Assessment:

a These criteria will be assessed as per the remedy reaction presented by the patient.         b On examination clinical signs.

  1. Statistical Assessment as follows

Outcome Assessment will be done based on before and after treatment symptom scores of Allergic Rhinitis Symptom Score ARSS.

i Improved – 26 to 100 percent           ii Not improved – less than 26 percent

Allergic Rhinitis Symptom Score ARSS

S.

No.

Symptom

0

1

2

3

4

|1

Nasal dis-charge

Absent

Watery

Mucoid

Mucopuru-

lent

  |2

Discharge sensation

Absent

Bland

Acrid

   |3

Discharge quantity

Absent

Scanty

Copious

   |4

Sneezing

Absent

Occasional

Infrequent

Constant

  |5

Nasal obstruction

frequency

Absent

Occasional

Always

   |6

Nasal obstruction Side

Absent

Unilateral

Bilateral compelled to mouth breathing

Post nasal dripping

  |7

Irritation in nose and eyes

Absent

Itching

Burning

Pain

  |8

Irritation in throat

Absent

Itching

Burning

Pain

  |9

Lachrymation watering eyes Quali-ty

Absent

Bland

Acrid

   |10

Lachrymation watering eyes Quantity

Absent

Occasional

Always

   |11

Malaise

Absent

  Present

  |12

Congestion of nasal mucosa

Absent

  Swollen, red

  |13

Congestion of nasal turbinates

Absent

  Swollen. red

  |14

Fever

Absent

Mild

Moderate

Severe

Hyperpy-

rexia

|15

Headache

Absent

Present

    |16

Anosmia

Absent

Present

Research methodology specified and explained for data collection

1. Sample sizeSample size is 40 patients.

2   Sampling techniqueNon probability purposive sampling will be based on Inclusion and Exclusion criteria.

3    Methods of data collection relevant to the objective

  1.    Clinically diagnosed Patients of Allergic Rhinitis will be enrolled from the outpatient department of the Institute.

  2.    Purposive Sampling of Allergic Rhinitis patients will be based on Inclusion and

Exclusion criteria

  1.    Homoeopathic case-taking will be done as per the proforma.

  2.    Clinical Examination for: Nasal congestion, inflamed turbinates and mucosa will be done.

4    Study instrument/data collection tools

  1.    Standardised homoeopathic case taking proforma.

  2.    Nasal Speculum.

  3.    Allergic Rhinitis Symptom Score of Allergic Rhinitis.

  4.    Appropriate reference books like Organon of Medicine, Medicine books, ENT books, Pathology books, Journals, and Research Papers will be considered.

  5.    Appropriate software will be used for the Repertorization of cases.

  6.    Written Informed Consent of 40 patients of Allergic Rhinitis will be taken from the OPD of the institute.

5   Data management and analysis procedure

  1.    Framing of the totality of symptoms: Totality will be done as per the principles of homoeopathy with special emphasis on Boger’s philosophy of formation of Totality of Symptoms.

  2.    Selection of remedy: Remedy will be given on the indicating totality of the patient.

  3.    The Posology: Potency and repetition will be done as per the susceptibility of the patient.

  4.    Patients will be given Individualized Homoeopathic medicines as per the indication.

Duration

1.     Duration of study 18 months.

2.     Duration of each case Each case will be studied for 6 months.

3.     Duration of Follow-up Each case will be followed up at the interval of 15 days or as and when required.

4.     ARSS will be calculated at 0 days,1 month, 3 months, 6 months.

6****Plan for Statistical Analysis

Statistical techniques

Data collected will be compiled into MS Office Excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency & percentage of categorical data, mean & Standard deviation of numerical data in each time interval will be depicted.

The normality of numerical data will be checked using the Shapiro–Wilk test or Kolmogorov-Smirnov test. Depending on the normality of the data, statistical tests will be determined.

研究设计

研究类型
Interventional

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients of Perennial Allergic Rhinitis.
  • Patients of age group 20 to
  • Patients of all genders.
  • Patients with controlled systemic comorbidities.

排除标准

  • Patients of Seasonal Allergic Rhinitis and Rhinoconjunctivitis.
  • Patients of Perennial Allergic Rhinitis with associated Nasal and Respiratory disorders such as bronchial asthma, sinusitis respectively.
  • Patients of Perennial Allergic Rhinitis with local comorbidities such as urticaria.
  • Immuno-compromised patients.
  • Pregnant or lactating women.
  • Patients on any medication like Antihistamines/ Antibiotics, within 3 months prior to the study.

结局指标

主要结局

Outcome will be assessed in terms of-

时间窗: Outcome will be assessed at 0 days (baseline), 1 month, 3 months, 6 months

1. Improved

时间窗: Outcome will be assessed at 0 days (baseline), 1 month, 3 months, 6 months

2. Not improved

时间窗: Outcome will be assessed at 0 days (baseline), 1 month, 3 months, 6 months

次要结局

未报告次要终点

研究者

发起方
Dr Riddhi Ladniya
申办方类型
Other [Self Sponsored]
责任方
Principal Investigator
主要研究者

Dr Riddhi Ladniya

DR. G. D. Pol Foundation YMT Homoeopathic Medical College and PG Institute

研究点 (1)

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