| CTRI Number |
CTRI/2024/02/062749 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Histaminum for Allergic Rhinitis. |
|
Scientific Title of Study
|
Utility of Histaminum in cases 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 Heta Harshil Tapiawala |
| Designation |
Post Graduate Student |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Vadodara |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Po.Limda,Ta.Waghodia,Dist.Vadodara
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Po.Limda,Ta.Waghodia,Dist.Vadodara
Vadodara
GUJARAT
392001
India |
| Phone |
9601881006 |
| Fax |
|
| Email |
heta.tapiawala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Acharya |
| Designation |
MD Homoeopathy |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Vadodara |
| Address |
Room No. 403 Homoeopathic Materia Medica Department, Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Po.Limda,Ta.Waghodia,Dist.Vadodara
Room No. 403 Homoeopathic Materia Medica Department, Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Po.Limda,Ta.Waghodia,Dist.Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9376225507 |
| Fax |
|
| Email |
jnhmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heta Harshil Tapiawala |
| Designation |
Post Graduate Student |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Vadodara |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Po.Limda,Ta.Waghodia,Dist.Vadodara
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Po.Limda,Ta.Waghodia,Dist.Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9376225507 |
| Fax |
|
| Email |
jnhmc@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Hospital Parul University,Vadodara |
|
|
Primary Sponsor
|
| Name |
Dr Heta Harshil Tapiawala |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University,Po.Limda,Ta.Waghodia,Dist.Vadodara |
| Type of Sponsor |
Other [SELF] |
|
|
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 Heta Harshil Tapiawala |
Jawaharlal Nehru Homoeopathic Hospital |
Room No.110, Jawaharlal Nehru Homoeopathic Hospital Parul University,Po.Limda,Ta.Waghodia,Dist.Vadodara
Vadodara
GUJARAT |
9601881006
heta.tapiawala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, (2) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Histaminum |
Intervention is planned as administering indicated homoeopathic medicine Histaminum form as decided to case. In this potency each dose shall consist of 4-5 globules(no. 30) of cane suger medicated of Histaminum (twice or thrice as per the need of case).Medicine to taken orally with empty stomach, dosage and repetition depending upon the individual requirement of the cases. Individual patient receives treatment for 6 months. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Samples of both sexes aged above 18 years will be taken.
2. All patients irrespective of socioeconomic status and geography will be taken for study.
3. Cases with pre diagnosed or having the clinical
features are included in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years of age and above 80 years are excluded.
2. Patients who are critically ill and with severe co morbidities like sinusities, asthma etc and bedridden patients are excluded.
3. Life threatening complications are excluded.
4. Cases with irregular follow ups are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of Histaminum in cases of Allergic Rhinitis in adult age group |
15 days,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the patient response to the medicine |
15 days, 30 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
25/02/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Allergic Rhinitis is also a global health problem, affecting 500 million patients worldwide (10 to 20% of the population).The prevalence of AR was reported to be 15%–25%. Children and adolescents, as well as young adults, were the age groups more affected by AR with co-morbidities of asthma, sinusitis, conjunctivitis, and nasal polyposis.
Homoeopathic treatment for allergies may be ideal because this type of therapy acts as an immunoregulator or immunomodulator, possibly regulating or reviving the immune system. Homoeopathy remedy Histaminum being one of the most effective lines of treatment, it can be helpful in treating Allergic Rhinitis with lifestyle modification. |