| CTRI Number |
CTRI/2022/06/043022 [Registered on: 06/06/2022] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to verify the symptoms of homoeopathic medicine Naphthalinum in cases of Allergic Rhinitis |
|
Scientific Title of Study
|
An Interventional Study To Assess The Effectiveness Of Naphthalinum In The Management Of Allergic Rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Bhinda |
| Designation |
PG Student |
| Affiliation |
Dr. M.P.K. Homoeopathic Medical College, Hospital and Research Center |
| Address |
Department of Materia Medica,Unit 1, Room 4, Homoeopathy University, 10,11,12, Hahnemann marg, Diggi malpura road, saipura,sanganer,jaipur-302029
Jaipur
RAJASTHAN
302018
India |
| Phone |
9461402056 |
| Fax |
|
| Email |
aditibhinda94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Tuteja |
| Designation |
Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Center |
| Address |
Department of Materia Medica Dr MPK Homoeopathic Medical College Hospital and Research centre a constituent college of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
drsoniatuteja@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Bhinda |
| Designation |
PG Student |
| Affiliation |
Dr. M.P.K. Homoeopathic Medical College, Hospital and Research Center |
| Address |
Department of Materia Medica,Unit 1, Room 4, Homoeopathy University, 10,11,12, Hahnemann marg, Diggi malpura road, saipura,sanganer,jaipur-302029
Jaipur
RAJASTHAN
302018
India |
| Phone |
9461402056 |
| Fax |
|
| Email |
aditibhinda94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Girendra Pal Homoeopathic Hospital and Research Center |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Center |
| Address |
!0,11,12, Hahnemann Marg,Diggi Malpura Road,Saipura, Sanganer,Jaipur, 302029 |
| 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 Aditi Bhinda |
Dr. Girendra Pal Homoeopathic Hospital and Research Center |
Department of Materia Medica, Unit 1, Room No. 4, Collegiate hospital of Dr. MPK Homoeopathic Medical College, Hospital and Research Center, 10,11,12, Hahnemann Marg, Diggi Malpura Road, Saipura, Sanganer, Jaipur
Jaipur
RAJASTHAN |
9461402056
aditibhinda94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, Homoeopathy University, Jaipur |
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 |
Naphthalinum |
Naphthalinum would be prescribed in 6c potency at the start of the treatment. The dosage schedule will be as per the requirement of the case. During the period of the study, the potency would be raised sequentially as per the need of the case, in pursuance of the homeopathic principles.
•Dosage: Naphthalinum 6C or 30C /TDS or bd for 7 days will be prescribed according to the need of the case
Repetition will be done every 5th day in cases of an acute attack and cases of amelioration every 7th day.
•Manufacturer- Medicine will be obtained from a GMP-certified company.
•Form- Globules No.30
•Route of administration- Oral
•Dispensing- This will be done by the college dispensary by a certified pharmacist.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnostic criteria: Presence of at least two typical symptoms mentioned below:
• nasal obstruction
• rhinorrhoea (also secretion running down the posterior pharynx)
• itching
• sneezing
occurring for more than an hour a day for more than 2 weeks in a year
2. Patients giving consent for the study.
3. Patients’ symptoms corresponding to Naphthalinum
4. Diagnosed cases of Allergic Rhinitis, taking treatment from other systems of medicine, feeling no relief and seeking homoeopathic treatment.
|
|
| ExclusionCriteria |
| Details |
1. Females, who want to conceive, are pregnant or lactating.
2. Patients with any other severe systemic disorder.
3. Patients pursuing other treatments are not willing to leave it.
4. Allergic Rhinitis complicated with any other serious disease.
5. Cases that need surgical intervention.
6. The cases require emergency treatment.
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the scores obtained (pre and post treatment) from the TNSS scoring method |
According to the scores obtained (pre and post treatment) from the TNSS scoring method at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To verify the symptoms of Naphthalinum in cases of Allergic Rhinitis. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/06/2022 |
| Date of Study Completion (India) |
28/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a non-randomized, open-label, single-arm, uni-center interventional trial to assess the effectiveness of Naphthalinum in the management of cases of Allergic Rhinitis. The primary outcome measures will be according to the scores obtained (pre and post-treatment) from the TNSS scoring method. The secondary outcome will be to verify the symptoms of Naphthalinum in the cases of Allergic Rhinitis. Null Hypothesis (H0) – Naphthalinum is not effective in the management of cases of Allergic Rhinitis. Alternate Hypothesis (H1) – Naphthalinum is effective in the management of cases of Allergic Rhinitis. |