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CTRI Number  CTRI/2022/03/040827 [Registered on: 04/03/2022] Trial Registered Prospectively
Last Modified On: 03/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Study The Efficacy OF Homoeopathic Medicine In Goitre 
Scientific Title of Study   Effectiveness Of Individualized Homoeopathic Medicine In Reducing The Size And Number Of Nodules In Multinodular Goitre : A Double – Blind Randomised Controlled Trail 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shagufta Naaz 
Designation  Post Graduate Scholar 
Affiliation  Kerala University Of Health Sciences 
Address  Department Of Practice Of Medicine, National Homoeopathy Research Institute In Mental Health, Kurichy

Kottayam
KERALA
686532
India 
Phone  8902241570  
Fax    
Email  snaazjma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R S Krishneswari 
Designation  Assistant Professor 
Affiliation  Kerala University Of Health Sciences 
Address  Department Of Practice Of Medicine, National Homoeopathy Research Institute In Mental Health, Kurichy

Kottayam
KERALA
686532
India 
Phone  9445646864  
Fax    
Email  krishneswarirs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R S Krishneswari 
Designation  Assistant Professor 
Affiliation  Kerala University Of Health Sciences 
Address  Department Of Practice Of Medicine, National Homoeopathy Research Institute In Mental Health, Kurichy

Kottayam
KERALA
686532
India 
Phone  9445646864  
Fax    
Email  krishneswarirs@gmail.com  
 
Source of Monetary or Material Support  
National Homoeopathy Research Institute In Mental Health, Kurichy, Kottayam, Kerala, India, Pin – 686532  
 
Primary Sponsor  
Name  Dr Shagufta Naaz 
Address  Department Of Medicine, National Homoeopathy Research Institute In Mental Health, Kurichy, Kottayam, Kerala, India, Pin – 686532  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shagufta Naaz  National Homoeopathy Research Institute In Mental Health  Department Of Medicine, NHRIMH, Kurichy, Pin - 686532
Kottayam
KERALA 		 8902241570

snaazjma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E042||Nontoxic multinodular goiter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicines  Individualised Homoeopathic Medicines Will Be Prescribed According To The Homoeopathic Principles. Each Eligible Participant Will Be Randomly Allocated Into Either Group A Or Group B By Randomisation Procedure. Group A And Group B Will Receive Individualised Homoeopathic Medicine And Placebo Respectively. Route Of Administration : Oral Dose : Medicine will be administered from lower to higher potency (6C, 12C, 30C, 200C, 1M, 10M, 50M, CM in case of Centesimal scale, and from LM1 tO LM20 in case of LM potency). The dosage and repetition will be decided considering the severity of condition and susceptibility of the patient. In case of acute complaints, medicine will be prescribed based on acute totality. Frequency : Each cases will be reviewed at 4 weeks interval, and if needed whenever necessary. The dosage and repetition will be decided considering the severity of condition and susceptibility of the patient ( As Per Requirement ). Duration Of Therapy : 1 Year  
Comparator Agent  Placebo  Each Eligible Participant Will Be Randomly Allocated Into Either Group A Or Group B. And Group B Will Receive Identical Placebo. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient with positive ultrasound result for evidence of multinodular goitre.

2. Patient with euthyroidism and subclinical hypothyroidism 
 
ExclusionCriteria 
Details  1. Patient below the age of 18 years.

2. Evidence of malignant change in ultrasonography and Fine Needle Aspiration Cytology.

3. Patient with complications such as signs and symptoms of excessive mechanical obstruction and pressure effects on adjacent structures which
is diagnosed by necessary investigations.

4. Goitre with hyperthyroidism.

5. Patient with any diagnosed severe systemic illness.

6. Immunocompromised patients.

7. Pregnant and lactating mothers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the change in size and number of nodules in multinodular goitre by ultrasonography.  1 year follow up 
 
Secondary Outcome  
Outcome  TimePoints 
1. To find out the changes in the neck circumference.

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

3. To determine the change in thyroid profile.

4. To find out commonly indicated Homoeopathic medicines effective in treatment of multinodular goitre. 		 1 year follow up 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 3 
Date of First Enrollment (India)   12/03/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
 
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