| CTRI Number |
CTRI/2025/04/085452 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
To investigate the effectiveness of individualized homeopathic remedies for chronic paranasal sinusitis, a study utilizing the Synthesis Repertory |
|
Scientific Title of Study
|
To study the efficacy of individualised homoeopathic remedy in cases of chronic paranasal sinusitis with the help of synthesis repertory |
| 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 SHUBHRA YADAV |
| Designation |
M.D. Homoeopathic Repertory Postgraduate Student |
| Affiliation |
Ahmedabad Homoeopathic Medical College and Sainath Hospital |
| Address |
Department of Homeopathic Repertory,
Ahmedabad Homoeopathic Medical
College,
Sainath Hospital,
Opposite Kabir Enclave,
Bopal Ghuma Road, Ghuma, Ahmedabad - 380058
Ahmadabad
GUJARAT
380058
India |
| Phone |
9586844770 |
| Fax |
|
| Email |
2204072030005@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devangi G Pandya |
| Designation |
Professor and Postgraduate Guide of Homoeopathic Repertory |
| Affiliation |
Ahmedabad Homoeopathic Medical College and Sainath Hospital |
| Address |
Department of Homeopathic Repertory,
Ahmedabad Homoeopathic Medical College,
Sainath Hospital,
Opposite Kabir Enclave, Bopal Ghuma Road, Ghuma,
Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600399549 |
| Fax |
|
| Email |
devangi.pandyaahmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SHUBHRA YADAV |
| Designation |
M.D. Homoeopathic Repertory Postgraduate Student |
| Affiliation |
Ahmedabad Homoeopathic Medical College and Sainath Hospital |
| Address |
Department of Homeopathic Repertory,
Ahmedabad Homoeopathic Medical
College,
Sainath Hospital,
Opposite Kabir Enclave,
Bopal Ghuma Road, Ghuma, Ahmedabad - 380058
Ahmadabad
GUJARAT
380058
India |
| Phone |
9586844770 |
| Fax |
|
| Email |
2204072030005@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Homoeopathic Medical College and Sainath Hospital.
Parul University,
Opposite Kabir Enclave,
Bopal Ghuma Road,
Ghuma,
Ahmedabad - 380058 |
|
|
Primary Sponsor
|
| Name |
DR SHUBHRA YADAV |
| Address |
M.D. Homoeopathic Repertory Postgraduate Student, Department of Homoeopathic Repertory,
Ahmedabad Homoeopathic Medical College and Sainath Hospital.
Opposite Kabir Enclave,
Bopal Ghuma Road,
Ghuma,
Ahmedabad - 380058 |
| Type of Sponsor |
Other [The principal investigator] |
|
|
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 SHUBHRA YADAV |
Ahmedabad Homoeopathic Medical College and Sainath Hospital |
Sainath Hospital,
Medicine and Pediatrics division,
Department of Homoeopathic Repertory.
Ahmadabad
GUJARAT |
9586844770
2204072030005@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research-Sainath Hospital, Ahmedabad (IECHR-Sainath Hospital) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
After case taking and totality of the symptoms formed. It is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition after case taking and repertorization utilizing either manual or computer repertorization. Each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated homoeopathic medicine, to be taken orally on clean tongue with empty stomach; dosage and repetition as per the individual requirements of each case.
Route of administration : Oral. Duration: Till the status of the patient changed as mentioned in the secondary outcome. |
| Comparator Agent |
Individualized Homoeopathic Medicine |
After case taking and totality of the symptoms formed. It is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition after case taking and repertorization utilizing either manual or computer repertorization. Each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated homoeopathic medicine, to be taken orally on clean tongue with empty stomach; dosage and repetition as per the individual requirements of each case. Route of administration : Oral. Duration: Till the status of the patient changed as mentioned in the secondary outcome. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All socioeconomic status
Pre-diagnosed cases of chronic paranasal sinusitis
Nasal Symptom Questionnaire Scale more than or equal to 10 |
|
| ExclusionCriteria |
| Details |
Previous sinus surgery
Cases associated with gross pathological changes
Pregnancy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nasal symptom questionnaire scale |
At the beginning before starting the treatment and at the follow up - every 07 to 15 days or as per the requirements. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nasal symptoms questionnaire scale for the relief of symptoms of nasal obstruction and rhinorrhoea as well as the presence or absence of systemic signs and symptoms utilizing three criteria:
Marked improvement: Characterized by a marked decrease in the intensity and frequency of presenting complaints, accompanied by an overall sense of well-being.
Moderate improvement: Indicates a substantial response with a notable decrease in the majority of symptoms.
Status Quo: No discernible increase or decrease in the symptoms of the patients. |
During follow-up for each case at regular interval of 7-15 days or as per specific requirements. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [2204072030005@paruluniversity.ac.in].
- For how long will this data be available start date provided 10-05-2025 and end date provided 30-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is randomized, participant blinded, single center trial to study the efficacy of the
individualized homoeopathic medicine with synthesis repertory in the treatment of chronic paranasal sinusitis. In this study participants
will be recruited as mentioned in inclusion and exclusion criteria. The case taking process will adhere to the guidelines outlined by Dr. Hahnemann in aphorism 83-104. Following a thorough analysis and evaluation of the case symptoms, the totality of symptoms will be formulated. Medicine
selection will be performed from the Synthesis repertory based on the totality of symptoms, utilizing either manual or computer repertorization. As an assessment tool Nasal Symptom Questionnaire Scale will be used. Various potencies of the selected medicines will be administered as per the individual requirements of each case. Follow up of each case will be taken at the interval of 7 to 15 days or as per the
requirement. Primary and secondary outcomes will be measured as mentioned earlier. |