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CTRI Number  CTRI/2023/11/060158 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 21/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical trial to study the effects of Histaminum Hydrochloricum and Individualised Homoeopathic remedy in Allergic Rhinitis 
Scientific Title of Study   Efficacy of Histaminum hydrochoricum 30 versus Individualised Homoeopathic medicine in reducing symptoms of Allergic Rhinitis : A Double Blind Randamised Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surya T P 
Designation  PG scholar, Department of practice of medicine 
Affiliation  National Homoeopathy Research Instituite in Mental Health, Kottayam 
Address  Department of practice of medicine, National Homoeopathy Research Instituite in Mental Health, Sachivothamapuram PO, Kottayam.

Kottayam
KERALA
686532
India 
Phone  9947163764  
Fax    
Email  suryathoppil123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RS Krishneswari 
Designation  Associate Professor, Department of practice of medicine 
Affiliation  National Homoeopathy Research Instituite in Mental Health, Kottayam 
Address  Department of practice of medicine, National Homoeopathy Research Instituite in Mental Health, Sachivothamapuram PO, Kottayam.

Kottayam
KERALA
686532
India 
Phone  9445646864  
Fax    
Email  krishneswarirs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr RS Krishneswari 
Designation  Associate Professor, Department of practice of medicine 
Affiliation  National Homoeopathy Research Instituite in Mental Health, Kottayam 
Address  Department of practice of medicine, National Homoeopathy Research Instituite in Mental Health, Sachivothamapuram PO, Kottayam.

Kottayam
KERALA
686532
India 
Phone  9445646864  
Fax    
Email  krishneswarirs@gmail.com  
 
Source of Monetary or Material Support  
National Homoeopathy Research Institute in Mental Heailth, Kottayam. PIN:686532 
 
Primary Sponsor  
Name  Surya T P 
Address  Department of practice of medicine, National Homoeopathy Research Instituite in Mental Health, Sachivothamapuram PO, Kottayam. 
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 Surya T P  National Homoeopathy Research Institute in Mental Health  OPD ,Dept. of Practice of medicine,National Homoeopathy Research Institute in Mental Health sachivothamapuram P.O, Kottayam-686532
Kottayam
KERALA 		 9947163764

suryathoppil123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NHRIMH Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine Histaminum hydrochloricum 30 in reducing symptoms of Allergic Rhinitis  Each participant will be randomly allocated to 2 groups. Group A will be given Histaminum hydrochloricum 30, through randomisation procedure. The Histaminum hydrochloricum 30 will be prescribed once in fortnight for Group A.The medicine 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. 
Comparator Agent  Individualized Homoeopathic Medicine in 30th potency.  Each participant will be randomly allocated to 2 groups. Group B will be given Individualized Homoeopathic Medicine in 30th potency, through randomisation procedure. The medicine will be prescribed once in fortnight for Group B . The medicine 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. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in TNSS score   once in a month for 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in IgE and AEC values.  once in 3 months for 1 year 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 2 
Date of First Enrollment (India)   30/11/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
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.
 
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