| CTRI Number |
CTRI/2021/04/032710 [Registered on: 09/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To know the effect of RUMA Spray in Acute Musculoskeletal Pain and Acute Sports Injury Pain |
|
Scientific Title of Study
|
An Open–Label, Two Arm Clinical Study to Evaluate the Efficacy and Safety of RUMA Spray in Acute Musculoskeletal Pain and Acute Sports Injury Pain Relief
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrLokesh Holagundi |
| Designation |
orthopedic surgeon |
| Affiliation |
Health India Hospital |
| Address |
Health India Hospital
No.7, 6th cross, tavarekere main road, chikkadugodi,
bangalore - 560029
No.7, 6th cross, tavarekere main road, chikkadugodi,
bangalore - 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
loksdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSrikrishna |
| Designation |
research scientist |
| Affiliation |
The Himalaya Drug Company |
| Address |
302, 3rd floor, clinical pharmacology, R and D,
makali, bengaluru
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.srikrishna@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSoorya Narayan H |
| Designation |
Clinical Trial Manager |
| Affiliation |
The Himalaya Drug Company |
| Address |
302, 3rd floor, clinical pharmacology, R and D
makali, bengaluru
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
Tumkur road, Makali Bangalore India, Bangalore 562162 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrAbdul Matheen |
Medlife Clinic |
Department of Medicine, room number 2, No.81, 5th main road, Minhajagar, kadrenehalli, banashankari stage 2, J P NAgar,
Bangalore
KARNATAKA |
9449767229
mateenathar@yahoo.co.in |
| DrLokesh Holagundi |
Health India Hospital |
Room no. 3, Ground floor, no.7, 6th cross, tavarekere main road,
chikkadugodi, bengaluru
Bangalore Rural
KARNATAKA |
95132249369
loksdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M95-M95||Other disorders of the musculoskeletal system and connective tissue. Ayurveda Condition: MAMSAGATAVATAKOPA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RUMA Pain relief Spray for acute muscular pain and Acute sports injury. |
Arm one is for Acute Muscular pain and Arm two is for Acute sports injury. RUMA Spray will be applied Maximum of 4 application to . (within 24 hours) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of either gender aged ≥18 - ≤65 years.
2.Subjects with Grade I and Grade II muscular sprains and joint pain.
3.Subjects suffering from Common musculoskeletal conditions - Back ache, joints pain (Wrist, elbow, shoulder, ankle, Knee, neck pain, sprains and strains / Sports and traumatic injuries.
4.Subjects willing to sign informed consent and follow with the schedule.
5.Subjects who have not participated in similar kind of study in last 4 weeks.
|
|
| ExclusionCriteria |
| Details |
1.subjects suffering from auto-immune disorders, spastic disorders, genetic disorders and severe traumatic conditions.
2.Any evidence or history of hypersensitivity to any of the components in the RUMA Spray
3.Any known skin disorder or presence of open wounds.
4.subjects who are taking any additional topical therapy or systemic NSAIDs.
5.Clinical diagnosis of bruises, trauma, muscle damage.
6.subjects with raw wounds, sutures, fractures and hematoma.
7.Pregnant or lactating women/women not willing to follow adequate standard contraceptive measures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time required for the onset of relief.
Time required for complete relief.
Time required for next successive application. |
quick relief |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the Visual Analogue Scale scoring on the successive application as compared to baseline.
Incidence of any adverse events during study.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/04/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| Composition of RUMA Bakuchi (Psoralea corylifolia) Maricha (Piper nigrum) Sarala (Pinus longifolia)
Gandhapura Taila (Gaultheria fragrantissima) Tila (Sesamum indicum) Karpura (Cinnamomun camphora) Pudina satva (Mentha arvensis) Ajmoda satva (Carum copticum)
This study is designed to evaluate the safety and efficacy of Pain relief spray and get quick relief in common Acute musculoskeletal pain like back pain, shoulder pain, knee pain sprain and strain and any Acute sports and traumatic injuries.
| |