Effectiveness Of Individualized Homoeopathic Medicine In Reducing The Size And Number Of Nodules In Multinodular Goitre : A Double – Blind Randomised Controlled Trail

Aim: To study the role of individualized Homoeopathic medicines in reducing the size and number of nodules in multinodular goitre.

Objectives:

1. Primary objective :

i) To determine the change in size and number of nodules in multinodular goitre by ultrasonography.

2. Secondary objectives :

i) To find out the changes in the neck circumference.

ii) To find out the change in symptomatology after administration of Homoeopathic medications.

iii) To determine the change in thyroid profile.

iv) To find out commonly indicated Homoeopathic medicines effective in treatment of multinodular goitre.

HYPOTHESIS:

NULL HYPOTHESIS (H0):

There is no significant reduction in the size of nodules in multinodular goitre in the Homoeopathic intervention group as compared to the placebo group.

There is no significant reduction in the number of nodules in multinodular goitre in the Homoeopathic intervention group as compared to the placebo group.

ALTERNATE HYPOTHESIS (H1):

There is significant reduction in the size of nodules in multinodular goitre in the Homoeopathic intervention group as compared to the placebo group.

There is significant reduction in the number of nodules in multinodular goitre in the Homoeopathic intervention group as compared to the placebo group.

METHODS :

A randomized controlled trial study will be conducted in the outpatient department of National Homoeopathy Research Institute in Mental Health, Kottayam. Cases from the inpatient departments as well as referral cases from the peripheral centres and camps can also be included in the study. After detailed screening and evaluation, all the baseline investigations, diagnostic tests and anthropometric measurements, patient between 18- 65 years of age, of both the sexes, fitting in the inclusion criteria will be informed about the trial and written consent will be taken and they will be enrolled in the study.

Randomisation and grouping :

Patients will be randomized into two groups. Each patient will be allocated to either group A (Homoeopathic medication) or group B (placebo only) as intervention through randomisation procedure. Patients and physicians including the investigator will be blinded in all the process to reduce the bias. Third-party will be assigning the particular individualized medicine or placebo to the patients as per the randomization. Coding will be done to the medicines and the placebo which will be revealed after the trial.

Treatment & follow up criteria :

All cases are subjected to a detailed case taking in standardized case record made for the purpose after which the totality is formulated. The cases coming under both the groups will be repertorized using Radar Opus and medicine will be prescribed after consultation with the Materia medica. Individualised Homoeopathic medicines will be prescribed only to group A. The medicine, their potency, dose and frequency of repetition will be determined according to Homoeopathic principles.As per the need and demand of the case, potency and repetition of medicine can be changed in the follow ups. Each cases will be reviewed at 4 weeks interval, and if needed whenever necessary. Laboratory investigations including Thyroid profile and Ultrasound of thyroid will be done for proper diagnosis of Multinodular Goitre. FNAC will be advised in order to rule out any malignancy and they will be excluded from the study. Investigations such as Thyroid profile will be repeated at baseline, third, sixth, ninth and twelfth month. And ultrasound of neck will be advised at baseline, sixth and twelfth month. Meanwhile other investigations will be carried if needed.

Outcome measurement:

The outcome measurement will be done by assessing the changes in the size and number of nodules in multinodular goitre through ultrasonography, analysing the changes in the Thyroid function tests and monthly analysing the neck circumference and symptomatic improvement in the patients using MYMOP and ORIDL SCORE after the administration of individualized homoeopathic medicine.