| CTRI Number |
CTRI/2020/11/028785 [Registered on: 02/11/2020] Trial Registered Prospectively |
| Last Modified On: |
30/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment for Allergic rhinitis |
|
Scientific Title of Study
|
Individualized Homoeopathic Treatment in Allergic Rhinitis by using the KENTs Repertory: A Randomized, Double-blind, Placebo-controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smriti Das |
| Designation |
Postgraduate trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College &Hospital |
| Address |
Department of Case taking and Repertory, OPD no 9, Mahesh Bhattacharyya Homoeopathic Medical College &Hospital
Haora
WEST BENGAL
711104
India |
| Phone |
9903827399 |
| Fax |
|
| Email |
drdassmriti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Purnendu Ash |
| Designation |
Lecturer |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College &Hospital |
| Address |
Department of Case taking and Repertory, OPD no 9, Mahesh Bhattacharyya Homoeopathic Medical College &Hospital
Haora
WEST BENGAL
711104
India |
| Phone |
9051420436 |
| Fax |
|
| Email |
purnendubhms29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Purnendu Ash |
| Designation |
Lecturer |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College &Hospital |
| Address |
Department of Case taking and Repertory, OPD no 9, Mahesh Bhattacharyya Homoeopathic Medical College &Hospital
Haora
WEST BENGAL
711104
India |
| Phone |
9051420436 |
| Fax |
|
| Email |
purnendubhms29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Drainage Canal Road, Doomurjala, Howrah, West Bengal, PIN-711104 |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College Hospital |
| Address |
Drainage Canal Road, Doomurjala, Howrah, West Bengal, PIN-711104 |
| Type of Sponsor |
Government 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 Smriti Das |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Department of Case taking and Repertory, OPD no 9, Drainage Canal Rd, Doomurjala,PIN-711104
Haora
WEST BENGAL |
09903827399
drdassmriti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Individualized Homoeopathic Medicines |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies. Each dose consists of 4-6 cane sugar globules moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally in empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of therapy: 4 weeks. |
| Comparator Agent |
Placebo |
This arm will be administered an identical looking placebo, indistinguishable from verum. Each dose consists of 4-6 cane sugar globules moistened with 90% v/v ethanol, to be taken orally in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from Allergic rhinitis (AR) for at least 1 year. Confirmative diagnosis of AR by medical history, symptoms, skin prick tests (SPTs) or other biochemical parameters.
2. Subject must be symptomatic at screening and willing to maintain same environment throughout the study.
3. Ability to read and write English or Bengali
4. Ability and willingness to comply with study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Having complications of the nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
2. Having complications of bacterial/viral infection of the upper respiratory tract
3. Having a significant systemic disease or any organ failure.
4. Subject suffering from any life threatening/Psychiatric/ illnesses or Immuno-compromised state or other significant disease conditions.
5. Pregnant or lactating woman
6. Substance abuse or dependence
7. Patients planning to travel outside the region
8. Patients who participated in another study within 4 months before screening
9. Patients taking drugs for other illness
10. Patients who have taken any homoeopathic medicines in the last 3 months.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Nasal Symptom Score (TNSS) |
baseline, 1st week, 2nd week, 3rd week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) |
baseline, 1st week, 2nd week, 3rd week and 4th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Allergic rhinitis (AR) is a major problem worldwide and millions of people are suffering from this condition. Homoeopathy has long been recognised for its effectiveness in AR. However, very few clinical trials are there evaluating the effect of Individualised Homoeopathy in AR cases. This study has been taken up to demonstrate the feasibility and effect of IH in such cases. The trial will be conducted in strict adherence to the Helsinki’s human declaration protocol. The results of this study will be of much interest to the therapeutic modalities for AR. |