| 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
|
|
|
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
|
|
|
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
|
|
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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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