| CTRI Number |
CTRI/2019/11/021874 [Registered on: 05/11/2019] Trial Registered Prospectively |
| Last Modified On: |
21/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial to test the efficacy and safety of topical application of IP in management of pain associated with muscles |
|
Scientific Title of Study
|
A clinical trial to evaluate safety & efficacy of Polyherbal Pain Relief Ointment (Topical Application) in the Management of musculoskeletal pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SYN/VAS/DAZ-008( Dated 22.7.19 version 1.0) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Saklecha |
| Designation |
Consultant Physician- General Medicine |
| Affiliation |
Santosh Hospital |
| Address |
Department of General Medicine, #6/1, Promenade Road, near Coles Park, Frazer Town, Bengaluru, Karnataka
Bangalore
KARNATAKA
560005
India |
| Phone |
9845306703 |
| Fax |
|
| Email |
ssaklecha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hardik Soni |
| Designation |
Sr. Manager |
| Affiliation |
Vasu Healthcare Pvt. Ltd. |
| Address |
A2/624-625/2, GIDC, Makarpura, Vadodara – Gujarat
Bangalore
KARNATAKA
390 010
India |
| Phone |
|
| Fax |
|
| Email |
hsoni@vasuresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
Director |
| Affiliation |
Syncorp Clincare Technologies Pvt. Ltd |
| Address |
186/2 Tapaswiji Arcade, 2nd floor,
BTM Layout 1st Stage,
Hosur Main Road,
Bangalore
KARNATAKA
560 068
India |
| Phone |
|
| Fax |
|
| Email |
subham@syncorp.in |
|
|
Source of Monetary or Material Support
|
| Vasu Healthcare Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Vasu Healthcare Pvt Ltd |
| Address |
A2/624-625/2, GIDC, Makarpura, Vadodara – 390 010, Gujarat |
| Type of Sponsor |
Other [Ayurvedic & Herbal Cosmetic Products Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubhransu Patro |
KIMS |
Kushabhadra Campus (KIIT Campus-5) Patia,
Bhubaneswar
Khordha
ORISSA |
9861056729
dr.shubhransu@gmail.com |
| Dr Santosh Saklecha |
Santosh Hospital |
6/1, Promenade Road, Near Coles Park, Frazer Town, Bengaluru, Karnataka 560005
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committee |
Approved |
| Santosh Hospital Institutional ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not aplicable |
| Intervention |
Polyherbal Pain Relief Ointment |
The Ointment is a combination of traditionally used aromatic oils with known as poly herbal pain-relieving effect such as joint and muscular sprain, backache, strain.
Gently massage Dazzle ointment over affected areas 2 or 3 times a day or as directed by Physicians.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of both genders with age ≥ 18 years.
2. Subjects who are willing to give written Informed Consent and willing to follow study procedures.
3. Subjects agreeing not to use any treatment for pain apart from the IP.
4. Subjects with documented diagnosis of moderate to severe pain with any of the condition, i.e.,
a. Sprains
b. Shoulder and neck stiffness
c. Backache
d. Miscellaneous Musculo - skeletal pain not classified above
5. Acute back pain, acute neck pain, acute musculoskeletal pain with no underlying pathology
6. Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
7. All concurrent medications taken for any reason stable for 14 days.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change Visual Analog Scale (VAS) score at Baseline and on day 1, 2, 3 and 7.
2. Change in NPRS score at baseline and on Day 1, 2, 3 and 7.
|
7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Patient compliance questionnaire
2. Any AE or SAE |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/11/2019 |
| Date of Study Completion (India) |
03/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a
prospective, open label, single-center 14 days Clinical Study to evaluate the
efficacy and Safety of Test formulation (Polyherbal Pain Relief
Ointment) in the management of Moderate
to severe pain. |