Efficacy of Histaminum hydrochoricum 30 versus Individualised Homoeopathic medicine in reducing symptoms of Allergic Rhinitis : A Double Blind Randamised Controlled Trial.

AIM

To evaluate the change in symptoms of Allergic Rhinitis with Histaminum hydrochloricum 30 as compared to Individualized Homoeopathic Medicine in 30th potency.

OBJECTIVES

Primary: To determine the efficacy of Homoeopathic Medicine Histaminum hydrochloricum 30 in reducing of symptoms of Allergic Rhinitis as compared with Individualized Homoeopathic Medicine in 30th potency.

Secondary:

1.To determine the efficacy of the Homeopathic Medicine Histaminum hydrochloricum 30 in reducing IgE and AEC in Allergic Rhinitis as compared to

Individualized Homoeopathic medicine in 30th potency.

2. To construct the clinical verification of symptoms of Histaminum hydrochloricum 30 after unblinding.

HYPOTHESIS

NULL HYPOTHESIS(H0)

Homoeopathic Medicine Histaminum hydrochloricum 30 has no significant effect in reducing symptoms of Allergic Rhinitis as compared to Individualized

Homoeopathic Medicine in 30th potency.

ALTERNATIVE HYPOTHESIS(H1)

Homoeopathic Medicine Histaminum hydrochloricum 30 has significant effect in reducing symptoms of Allergic Rhinitis as compared to Individualized

Homoeopathic Medicine in 30th potency.

STUDY DESIGN

A Double Blind- Randomised Controlled Trial

STUDY SETTING

The study will be conducted in the patients coming with Allergic Rhinitis from the Outpatient Department, peripheral centers and camps under the Department of Practice of Medicine of National Homoeopathy Research Institute in Mental Health, Kottayam.

STUDY POPULATION

Cases presented with features of Allergic Rhinitis in outpatient department ,Peripheral centre and camps under the department of Medicine of NHRIMH Kottayam

STUDY DURATION:

Total duration of 18 months (12 months follow up and 6month enrollment)

SAMPLING

i. Sample size

Due to lack of availability of data with similar studies, this study being the first of its kind- A double blind randomized controlled trial- a sample size of 30 was selected in each group. Considering 20% drop out, 36 cases may be enrolled in each group.

ii.Inclusion criteria.

1. Clinically diagnosed cases of allergic rhinitis

2. Both sexes of age 18-60 years

3. Patients with serum IgE level above 150 IU/ml or Absolute Eosinophil Count level above 440 cells/microlitre.

iii.Exclusion criteria

1. Patients with severe systemic illnesses like Hypertension, Diabetes Mellitus.

2. Patients complicated with sinusitis,otitis media

3. Patients on other medication for allergic rhinitis

4. Patients with bronchial asthma

5. Pregnant ladies and lactating mothers

iv. Sampling procedure

Purposive sampling

METHODS

i) Methods of data collection:

A randomized controlled trial will be conducted in the Outpatients Department, peripheral centers and camps under the Department of Practice of Medicine of National Homoeopathy Research Institute in Mental Health, Kottayam. After preliminary screening , patient will be analysed for Complete Blood Count, IgE and AEC for diagnosis of Allergic Rhinitis. The patient satisfying the inclusion and exclusion criteria will be enrolled in the study after getting written informed consent signed.

Each participant will be randomly allocated to either group A (Histaminum hydrochloricum 30 medication) or group B (Individualized

Homoeopathic medicinein 30th potency) through randomisation procedure. The medicine and potency will be selected according to the Repertorisation chart.

Randomization will be done by using block randomization procedurehttps://www.sealedenvelope.com/simple-randomiser/v1/lists. Patients, investigator and guide will be blinded in all the process to reduce the bias. Third party will be assigning Histaminum hydrochloricum 30 or Individualised Homoeopathic medicine in 30th potency according to the Randomisation chart. The Histaminum hydrochloricum 30 will be prescribed once in fortnight for Group A and Group B will be receiving Individualised Homoeopathic medicine once in fortnight for first month. Histaminum hydrochloricum 30 and Individualized medicin in 30th potency will be prescribed until there is marked improvement. Advice for general management give equal to all participant in this study. There is no reduction of symptom of patient or patient condition is worsening then unblinding of particular patient will be done and give standard care will be given. All Cases will be followed up for a period of 12 months. Change in TNSS score will be assessed once in a month and values of IgE and AEC will be assessed once in 3 months.

In acute complaint ,acute homoeopathic remedy will be prescribed after taking acute totality, it will be documented and record of this will

be maintained. The individualized medicine erected from totality is prescribed in post trial care.

Outcome measurement:

Outcome of the study will be measured by assessing:

1. Change in TNSS score (once in a month)

2.Reduction in IgE and AEC values (once in 3 months)

Dropout Criteria:

Telephonic follow ups may be done for the patients those who are not visiting OPD properly. But if the patient is not reporting for 3 or more consecutive follow-ups even after telephonic follow-ups the patient will be dropped out from the study.

Withdrawal Criteria:

If there is any adverse reactions or serious adverse events noted after administration of Homoeopathic medicine. it will be reported to the institutional pharmacovigilance department. If any complications occur, they will be referred to higher centres and will be dropped out from the study and if they are returning for treatment, they will not be included in the study and will be given standard treatment.