| CTRI Number |
CTRI/2024/11/077394 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Investigating The Main Themes Of The Magnolidae Group Of Medicines In Literature And Confirming Their Efficiency By Giving These Medicines And Analyzing The Results In Patients |
|
Scientific Title of Study
|
Verifying The Themes Of The Remedies From First Subclass Magnolidae From The Dicotyledon Classification Of The Plant Kingdom And Its Evidence Based Clinical Trials |
| 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 Chandrashekhar Vishwanath Algundgi |
| Designation |
Ph.D Research Scholar |
| Affiliation |
Vidhyadeep Homoeopathic Medical College And Research Centre, Anita, Kim, Vidhyadeep University |
| Address |
Room No. 04 Vidhyadeep Homoeopathic Medical College And Research Centre Vidhyadeep University, Anita, Kim, Olpad
Room No. 04 Vidhyadeep Homoeopathic Medical College And Research Centre Vidhyadeep University, Anita, Kim, Olpad
Surat
GUJARAT
394110
India |
| Phone |
919324524268 |
| Fax |
|
| Email |
academy.swara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar Vishwanath Algundgi |
| Designation |
Ph.D Research Scholar |
| Affiliation |
Vidhyadeep Homoeopathic Medical College And Research Centre Vidhyadeep University, Anita, Kim, Olpad |
| Address |
Room No. 04 Vidhyadeep Homoeopathic Medical College And Research Centre Vidhyadeep University, Anita, Kim, Olpad
Room No. 04 Vidhyadeep Homoeopathic Medical College And Research Centre Vidhyadeep University, Anita, Kim, Olpad
Surat
GUJARAT
394110
India |
| Phone |
919324524268 |
| Fax |
|
| Email |
academy.swara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipul R Shastri |
| Designation |
Principla of VHMC and RC, I/C Provost of Vidhyadeep University, Guide |
| Affiliation |
Vidhyadeep Homoeopathic Medical College And Research Centre Vidhyadeep University |
| Address |
Room No. 04 Vidhyadeep Homoeopathic Medical College And Research Centre Vidhyadeep University, Anita, Kim, Olpad Surat
Surat
GUJARAT
394110
India |
| Phone |
09824109174 |
| Fax |
|
| Email |
drvipulshastri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 04 Homoeopathy Dept, Vidhyadeep Homoeopathic Medical College And Research Centre, Vidhyadeep University, Anita, Kim, Surat, 394110
|
|
|
Primary Sponsor
|
| Name |
the Other Song Homeopathy Clinic |
| Address |
702, Peninsula Heights,
C. D. Burfiwala Marg,
Juhu Lane, Andheri West,
Mumbai, Maharashtra 400058
|
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vidhyadeep Homoeopathic Medical College and Research Center |
Vidhyadeep University, Anita, Kim, Surat, 394110 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrashekhar V Algundgi |
Vidhyadeep Homoeopathic Medical College And Research Centre |
Room No. 04, Homoeopathy Dept., Vidhyadeep Homoeopathic Medical College And Research Centre, Vidhyadeep University, Anita, Kim, Surat
Surat
GUJARAT |
919324524268
academy.swara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who are willing to provide their consent for their detailed Case taking, willing to take the indicated Remedy & appear for regular follow-ups to comply with study protocol
2) Cases having the themes of the first Subclass
|
|
| ExclusionCriteria |
| Details |
1) Children below 8 years of age and adults above 70 years of age.
2)Pregnant & Nursing women
3) Patients who have taken Homeopathic medicine within the last 6 weeks are excluded
4) Non-compliance with medication or treatment regimen.
5) People who have participated in another clinical trial within the last six months are excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To compile common themes across different orders within Subclass 1 by examining various remedies from each order
2) Based on the above compilation formulating the central theme of the entire first subclass
|
Baseline, 6 weeks, and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Assembling the cases in categories following the themes of the remedies from the first Subclass
2) Verifying the compiled central theme of first subclass in all the Cases
|
Baseline, 6 weeks, & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
09/12/2024 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
This research aims to address the evidence gap regarding the clinical presence of themes associated with the remedies of the first subclass, Magnolidae, within the dicotyledon classification. These themes are derived from proving data gathered from various authors.
The research objectives consist of two components:
1. To compile common themes across different orders within Subclass 1 by examining various remedies from each order, thereby constructing a central theme representative of Subclass 1 (The Magnolidae).
2. To clinically validate these themes across a diverse range of patients, encompassing different age groups, genders, and medical conditions, through the application of indicated remedies from Subclass 1 and assessing their effectiveness in treating patients’ ailments.
This research will provide insights into how treatments grounded in systematic scientific data collection can yield improved outcomes when applied in clinical practice with greater certainty.
|