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CTRI Number  CTRI/2024/06/069330 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on role of Homoeopathic medicine Histaminum hydrochloricum in LM potency in management of Allergic rhinitis 
Scientific Title of Study
Modification(s)  
Randomised Placebo Control and Parallel Arm Trial to assess the Effectiveness of Histaminum hydrochloricum in Ascending LM potency on Management of Allergic rhinitis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr AMALA M 
Designation  Post graduate student 
Affiliation  Sarada krishna Homoeopathic Medical College 
Address  3rd floor college building , Department of Practice of Medicine, Sarada Krishna homoeopathic medical college, Kulasekharam , Kanniyakumari, Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  8848958032  
Fax    
Email  amalasreekumar15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N V Sugathan 
Designation  Professor and Principal 
Affiliation  Sarada krishna Homoeoapthic Medical College 
Address  3rd floor college building , Department of Practice of Medicine, Sarada krishna homoeopathic medical college, Kulasekharam , Kanniyakumari, Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443558786  
Fax    
Email  drnvsugathan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr N V Sugathan 
Designation  Professor and Principal 
Affiliation  Sarada krishna Homoeoapthic Medical College 
Address  3rd floor college building , Department of Practice of Medicine, Sarada krishna homoeopathic medical college, Kulasekharam , Kanniyakumari, Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443558786  
Fax    
Email  drnvsugathan@gmail.com  
 
Source of Monetary or Material Support  
Institution-Sarada krishna Homoeopathic Medical College,Kulasekharam, kanniyakumari, Tamilnadu 629161  
 
Primary Sponsor  
Name  Sarada Krishna Homoeopathic Medical College 
Address  Sarada krishna Homoeopathic Medical College,Kulasekharam, kanniyakumari, Tamilnadu 629161 
Type of Sponsor  Private medical college 
 
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 Amala M  Sarada krishna Homoeopathic Medical College, Hospital  OPD,IPD of 3B Unit, Department of practice of medicine,Room No 104, Rural centers of sarada krishna Homoeopathic Medical, College,Kulasekharam,Kanniyakumari 629161
Kanniyakumari
TAMIL NADU 
8848958032

amalasreekumar15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics commitee Sarada krishna Homoeopathic Medical College   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  Histaminum hydrochloricum  Medicine will be administered in ascending LM potency,3 dose a week on alternate days for a period of 6 months potency change is done as per the requirement of the case during the follow up period 
Comparator Agent  Placebo and Nasal saline  Placebo administered 3 dose a week on alternate days up to 6 months and nasal saline is administered throughout the study unless any adverse events occur. in that instance, patient will be excluded from the study and will be administered with suitable intervention 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient clinically diagnosed with allergic rhinitis.
Patients having elevated serum IgE levels above 200 Iu/ml
Age limit 5 to 50 years
Both genders are included
 
 
ExclusionCriteria 
Details  Patients with only DNS, nasal polyp associated rhinitis is excluded.
Patients with serious extended chest infections are excluded.
Patients having other IgE mediated hypersensitivity reactions like urticaria, atopic dermatitis. Are excluded from the study
Pregnant and breast-feeding women
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Study is expected to show reduction in symptoms and recurrence of the allergic rhinitis in patients under Histaminum Hydrochloricum than control group
Lowering of serum IgE and AEC levels in group under homoeopathic medication
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life of the patient  6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 4 
Date of First Enrollment (India)   02/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  


Histaminum hydrochloricum is a potent medicine that can offer near antihistaminic effect. The effect of Histaminum on basophils have been explored through various invitro studies and found that Histaminum have significant inhibitory effect on basophil activation. However, there is no adequate clinical research done and published on the clinical effectiveness of Histaminum on the same even though Histaminum is suitable in many of the cases with atopic background. Conditions like allergic rhinitis are having a severe acute phase so immediate and frequent administration of medicines are needed to management of condition effectively. To achieve this without aggravation 50 millesimal potency is used throughout the study. Hence this research aims on the clinical applicability of Histaminum hydrochloricum in LM potency in cases of allergic rhinitis.

 Patients are chosen in to the study on the basis of inclusion and exclusion criteria .Patients suiting the totality of Histaminum hydrochloricum is taken in to the study and is randomly divided in to control and interventional group.20 cases are randomly classified as control group and 20 cases as interventional group. Control group is administered with placebo and nasal saline.

Other 20 cases are selected as the interventional group administered with Histaminum hydrochloricum in ascending LM potency as per the requirement of the patient. Histaminum hydrochloricum starting with 0/1 potency followed by successive higher potencies. Medicine is repeated as per the requirement of the case. Pre and post assessment of serum IgE, AEC is done in all the patients. Assessment of the patient is done using total nasal symptom scoring and rhinitis control assessment test. Medicine is repeated on a weekly basis and follow up is done every week.

Post assessment of IgE AEC is done within 6 months and score assessment is done once in a month. Statistical analysis is done using paired t test.



 
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