| CTRI Number |
CTRI/2025/02/080303 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Homeopathy in Acute Tonsillitis |
|
Scientific Title of Study
|
AN EXPERIMENTAL STUDY TO ASCERTAIN EFFECTIVENESS OF OCIMUM SANCTUM IN CASES OF ACUTE TONSILLITIS IN CHILDREN OF 5-15 YEARS AGE GROUP WITH THE HELP OF BRODSKY GRADING SCALE |
| 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 Varshaben K Sarvaiya |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homeopathic Medical College, Parul University |
| Address |
B/h Jaynath Complex,Makkam Chowk, Gondal Road, Rajkot
Department of Homeopathic Materia Medica, Rajkot Homeopathic Medical College, Parul University
Rajkot
GUJARAT
360002
India |
| Phone |
|
| Fax |
|
| Email |
varshasarvaiya1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KAMNA Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homeopathic Medical College, Parul University |
| Address |
B/h Jaynath Complex, Makkam Chowk, Gondal Road,Rajkot
Department of Homeopathic Materia Medica, Rajkot Homeopathic Medical College, Parul University
Rajkot
GUJARAT
360002
India |
| Phone |
7021682692 |
| Fax |
|
| Email |
drkamnagupta@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamna Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homeopathic Medical College, Parul University |
| Address |
B/h Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot
Department of Homeopathic Materia Medica, Rajkot Homeopathic Medical College, Parul University
Rajkot
GUJARAT
360002
India |
| Phone |
7021682692 |
| Fax |
|
| Email |
drkamnagupta@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Sainath Homeopathic Hospital |
|
|
Primary Sponsor
|
| Name |
Rajkot Homeopathic Medical College Parul University |
| Address |
B/h Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot
Gujarat
360002
India |
| 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 Varshaben K Sarvaiya |
Sainath Homeopathic Hospital |
Department of Homeopathic Materia Medica,Rajkot Homoeopathic Medical College, Parul University
B/h Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot
Gujarat
360002
Rajkot
GUJARAT |
7043229290
varshasarvaiya1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research-Rajkot Homeopathic Medical College (RHMC) Parul University rajkot (IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J00-J06||Acute upper respiratory infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Ocimum Sanctum |
Ocimum Sanctum medicine at 2 days interval for one week and study to be conducted for 9 months to one year. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All type of acute tonsillitis.
Patient who are willing to give consent. |
|
| ExclusionCriteria |
| Details |
Age above 15 and below 5 not included.
Patient taking any alternative treatment for the same complaint.
Cases with other respiratory tract infection.
Patient with pathological changes present in acute tonsillitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the effectiveness of Ocimum sanctum in cases of acute tonsillitis. To study sign and symptoms of Ocimum sanctum related to tonsillitis. To assess the clinical utility of Brodsky Gradindg Scale. |
This will be achieved within 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| For the effective assessment and evaluation of disease intensity will also be maintained according to Brodsky Gradaing Scale. |
This will be achieved within 12 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 2 |
|
Date of First Enrollment (India)
|
19/02/2025 |
| 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
|
THE MATERIAL UTILIZED FOR THE STUDY: Informed consent i.e., to be signed by every patient. A specialized designed Case taking proforma. (Note all the records, forms and reports of the patient will be kept confidential.) Suitable Materia medica books, journals, articles, medicine and surgery books from our college central library and information from authentic online sites. The medication will be provided by the dispensary of Sainath Homoeopathic Hospital.
INTERVENTION GUIDELINES: After proper analysis &evaluation of the symptoms of the case. Totality of symptoms will be formed. Ocimum sanctum medicine will be given to the suitable patients. Potency, dose and repetition are determined by the patient’s susceptibility
CASE-TAKING: Case Taking will be done according to guidelines given by Dr. Hahnemann in Aphorism 83-104.
SELECTION OF MEDICINE: Ocimum sanctum medicine will be given to the suitable patients.
SELECTION OF POTENCY: Potency selection are done according to principles laid in Organon of medicine.
DOSE & REPETITION: Dose and Repetition of remedy will be done according to Homoeopathic principles laid down in Organon of Medicine.
FOLLOW UP AND MONITORING: Follow ups of each case will be taken at 2 days intervals or as per requirement (based on individual case).
RECORDS: Patient’s History, Report and Follow ups will be kept in record in soft and hardcopy
|