| CTRI Number |
CTRI/2025/09/094593 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
safety and efficacy of Sakriyam Pain Oil for the patients with Muscular pain |
|
Scientific Title of Study
|
An Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of
Sakriyam Pain Oil for the patients with Muscular pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGCTS/25/447 Version 1.0 dated 11 June 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Sharma |
| Designation |
Principal Investigator |
| Affiliation |
GS Ayurveda Medical College & Hospital Pilkhuwa Hapur |
| Address |
Ground floor, room no.2, Dept of General Medicine GS Ayurveda
Medical College & Hospital Pilkhuwa Hapur
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7906672912 |
| Fax |
|
| Email |
sharmamanjo39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate,
Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| GHK PHARMACEUTICALS PRIVATE LIMITED, N Terrance, FH 02 402, GTM Forest AndHills, Besides Aerodine Restaurant Mohkampur Khurd, Dehradun- 248005 |
|
|
Primary Sponsor
|
| Name |
GHK PHARMACEUTICALS PRIVATE LIMITED |
| Address |
N Terrance, FH 02 402, GTM Forest AndHills, Besides Aerodine Restaurant Mohkampur Khurd, Dehradun- 248005 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Sharma |
GS Ayurveda Medical College & Hospital |
Ground floor, Room
no.2, Dept of General
Medicine GS Ayurveda
Medical College &
Hospital Pilkhuwa
Hapur
Meerut
UTTAR PRADESH |
7906672912
sharmamanjo39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GS Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Sakriyam Pain Oil |
Dose: Apply oil two times a day Route of
Administration: Topical Duration: 30 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having Muscular pain.
2. Subjects from 18 to 65 years of age.
3. If female with childbearing potential, must be willing to practice an
acceptable form of birth control for the duration of the study.
4. Subjects that are able to give written informed consent in a manner
approved by the institutional ethics committee and comply with the
requirements of the study.
5. Subjects willing to avoid participation in any other interventional
clinical trial for the duration of the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects that are pregnant, breast feeding, or planning to get pregnant
during the study.
2. Subjects that have participated in any other interventional clinical trial
in the previous 30 days.
3. Subjects with known sensitivity to any of the constituents of the
investigational product. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in SGA score
2. Change in WOMAC score
3. Change in Musculoskeletal Health score |
Time Frame Day1, Day15 and Day30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in VAS score
2. Change in EQ-5D-5L Score |
Time Frame Day1 and Day30 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="0"
Months="1"
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
|
An In-vivo study, Each participant entering the trial will be assigned to a regimen of investigational product, and advised to take general precautions as needed. This study for 30 days in which Day 0 (Visit 1/Screening) done for screening purpose and handover the IP to the Subjects, and measure SGA, WOMAC, Musculoskeletal Health , VAS , EQ-5D-5L The next visits- day 15, and day 30 involve WOMAC, VAS , EQ-5D-5L , Musculoskeletal Health Questionnaires. Investigational Product: Sakriyam Pain Oil Age criteria- 18 to 65 years Test Product: Sakriyam Pain Oil, Dose: Apply oil two times a day, Route of Administration: Topical
|