| CTRI Number |
CTRI/2024/12/077576 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Pilot Clinical Study Exploring the Safety and Effectiveness of SPONDYGON-P50 Tablets for Managing Spondylosis |
|
Scientific Title of Study
|
Pilot exploratory clinical study to evaluate the safety and efficacy of SPONDYGON P50 tablet in the management of Spondylosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilima Dharkar |
| Designation |
Principal investigator |
| Affiliation |
Dr D Y Patil college of Ayurved and Research centre Pimpri Pune |
| Address |
Department of rasashashtra evum bhaishajyakalpana third floor Dr D Y Patil college of Ayurved and Research centre Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8390077907 |
| Fax |
|
| Email |
dharkar.nilima07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilima Dharkar |
| Designation |
Principal investigator |
| Affiliation |
Dr D Y Patil college of Ayurved and Research centre Pimpri Pune |
| Address |
Department of rasashashtra evum bhaishajyakalpana third floor Dr D Y Patil college of Ayurved and Research centre Pimpri Pune
MAHARASHTRA
411018
India |
| Phone |
8390077907 |
| Fax |
|
| Email |
dharkar.nilima07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilima Dharkar |
| Designation |
Principal investigator |
| Affiliation |
Dr D Y Patil college of Ayurved and Research centre Pimpri Pune |
| Address |
Department of rasashashtra evum bhaishajyakalpana third floor Dr D Y Patil college of Ayurved and Research centre Pimpri Pune
MAHARASHTRA
411018
India |
| Phone |
8390077907 |
| Fax |
|
| Email |
dharkar.nilima07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurved and Research centre Pimpri Pune Maharashtra India 411018 |
|
|
Primary Sponsor
|
| Name |
Sudhatatva Pharmacy |
| Address |
Dr D Y Patil college of Ayurved and Research centre Pimpri Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nilima Dharkar |
Dr D Y Patil college of Ayurved and Research centre |
Kayachikitsa OPD room no 5 Dr D Y Patil college of Ayurved and Research centre Pimpri Pune 411018
Pune
MAHARASHTRA |
8390077907
dharkar.nilima07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M47||Spondylosis, (2) ICD-10 Condition:M45-M49||Spondylopathies. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: SPONDYGON P50, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 400(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Comparator Agent |
NA |
NA |
| Intervention |
Spondygen p50 |
it is the combination of Sameerpannag Ras and Mahavat-Vidhvansan ras and Ekangavir Ras and Trikatu extract and Palash Extract and Vacha Extract |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from spondylosis from the age group of 30–70 years of either sex were selected
2. History of Spondylosis less than 5 years.
3. Patient willingly ready for informed consent
|
|
| ExclusionCriteria |
| Details |
1. The patients who had history of uncontrolled diabetes and uncontrolled systemic arterial hypertension, severe anemia with serum hemoglobin level less than 6 percent.
2. Individuals with any congenital deformity related to spine.
3. Individuals with known allergies to ingredients of interventional drug.
4. Pregnant or breastfeeding women.
5. Recent participation in another clinical trial
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anticipated outcome for the pilot exploratory clinical trial of spondygen p50 in spondylosis is that will significantly reduce the pain and ease the daily activity. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhance quality of life with better safety and tolaribility |
28 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/12/2024 |
| 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="1"
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
|
The pilot clinical study aimed to evaluate the safety and effectiveness of Spondygon P50 tablets in managing spondylosis, a degenerative condition affecting the spine. The study likely involved group of 30 participants diagnosed with spondylosis, focusing on Measuring improvements in symptoms such as pain, mobility, and quality of life. |