| CTRI Number |
CTRI/2024/11/076507 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Pharmaceutical-Clinical Study Of Vedanasthapan Mahakashaya In Two Different Dosage Form In Pain. |
|
Scientific Title of Study
|
A Comparative Pharmaceutical And Clinical Study Of Vedanasthapan Mahakashaya Oil And Vedanasthapan Mahakashaya Gel In Pain Management. |
| 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 Ragini Chaudhary |
| Designation |
M D Scholar Rasa Shastra And Bhaishajya Kalpana |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Government P.G Ayurvedic College And Hospital, Varanasi, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9044763401 |
| Fax |
|
| Email |
coolragini27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Kumar Gupta |
| Designation |
Reader |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Government P.G Ayurvedic College And Hospital, Varanasi, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9532016160 |
| Fax |
|
| Email |
drankitg01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kumar Pandey |
| Designation |
Professor |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Government P.G Ayurvedic College And Hospital, Varanasi, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9417077401 |
| Fax |
|
| Email |
dr.spandey2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G Ayurvedic College And Hospital, Varanasi, Uttar Pradesh, India, 221002 |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT P.G AYURVEDIC COLLEGE AND HOSPITAL,VARANASI |
| Address |
DEPARTMENT OF RASA SHASTRA AND BHAISHAJYA KALPANA, GOVERNMENT P.G AYURVEDIC COLLEGE AND HOSPITAL,VARANASI |
| 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 Ragini Chaudhary |
Government P.G. Ayurvedic College And Hospital, Varanasi |
Department Of Rasashastra And Bhaishajya Kalpana
Varanasi
UTTAR PRADESH |
9044763401
coolragini27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government P.G. Ayurvedic College And Hospital, Varanasi, U.P, Mahayogi Guru Gorakhnath Ayush University, Gorakhpur, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: SULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Vedanasthapan Mahakashaya Gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vedanasthapan Mahakashaya Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having Age of 16 year to 70 year,
2.Muscular pain or Nervous pain,
3.Assessing the site and severity and nature of Pain,
4.Knee, Shoulder, Lower Back Pain with mild and moderate Pain. |
|
| ExclusionCriteria |
| Details |
Patients having following sign and symptoms are not considerd in treatment:
1.Pain associated with Swelling,
2.Pain associated with Fracture,
3.Patients having any Hypersensitive skin allergy,
4.The patient suffering from Tuberculosis, Cancer, Rheumatoid Arthritis, Leucoderma, Psoriasis, severe skin infection or allergies etc.
5.Pregnant and Lactating women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain |
15 Days, 30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete Relief in Pain |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/11/2024 |
| 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="2"
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 study is interventional study trial comparing the efficacy of Vedanasthapan Mahakashaya in two different dosage form. Patients will be randomly selected from OPD of Department of Rasa Shastra And Bhaishajya Kalpana and Kayachikitsa department, at government P.G ayurvedic college and hospital , varanasi.
60 patients will be studied under 2 groups having 30 patients in each group.
Group A- 30 Patients will be treated by Vedanasthapan Mahakashaya Oil for 30 days. Group B- 30 Patients will be treated by Vedanasthapan Mahakashaya Gel for 30 days. |