| CTRI Number |
CTRI/2021/07/034690 [Registered on: 08/07/2021] Trial Registered Prospectively |
| Last Modified On: |
13/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study on “Ortho21†of OnTop Vedics as a Pain Relief Oil. |
|
Scientific Title of Study
|
An Open Label, Prospective, Randomised, Comparative, Two Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Ortho21†of OnTop Vedics as a Topical Treatment for Relief from Chronic and Acute Pain in Adult Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/ORT/069/21 Version 01 29-Mar-21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VTSriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
Raam Clinic, Room No 1,
Department of General /Family Medicine,
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VTSriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
Raam Clinic, Room No 1,
Department of General /Family Medicine,
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VTSriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
Raam Clinic, Room No 1,
Department of General /Family Medicine,
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| OnTop Vedics – A Division of OnTop Pharmaceuticals
G-1, Satya Mansion, Ranjit Nagar,Commercial Complex,
New Delhi – 110008.
|
|
|
Primary Sponsor
|
| Name |
OnTop Vedics A Division of OnTop Pharmaceuticals |
| Address |
G-1, Satya Mansion, Ranjit Nagar, Commercial Complex,
New Delhi – 110008.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Room No 1,
Department of General /Family Medicine,
180-109, G1 and G2, RR Villa,
Rangarajapuram main road,
Kodambakkam, Chennai, 600024.
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Ortho21 Advanced Pain Relief Oil |
Dose: Desired Quantity of Oil
Dosage: Treatment Arm I - Once a Day, take a small quantity of Ortho21 and massage gently topically on the area with pain. Do not apply bandage on top.
Treatment Arm II - Twice a Day, Once in the morning once in the night take a small quantity of Ortho21 and massage gently topically on the area with pain. Do not apply bandage on top.
Treatment Duration: 01 Month per enrolled subject.
Route of Administration: Topical. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects between the ages of 21 and 65 years (Both ages and all genders inclusive) with chronic pain attributed to arthritis and or acute pains such as sprains, muscle aches.
2. Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving joint pain, joint and muscle health.
3. Subjects who are willing to abstain from use of any topical ointment, cream etc that are indicated for mitigating pain and aches.
4. Subjects who have a pain score of 2-5 on a 10 point NRS at the time of screening in a minimum of one joint.
5. Subject who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to the ingredients of the investigational product.
2. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
3. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
4. Subjects on remission from cancer of any type less than 5 years at the time of screening.
5. Subjects who are planning a pregnancy and - or currently breastfeeding.
6. Subjects who have participated in a clinical study less than 1 month before screening.
7. Any significant medical condition -e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc -, any medical condition that is unstable or poorly controlled or other factor -eg., planned relocation - that investigator felt would interfere with study evaluations and study participation.
8. Subjects who are unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
9. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Brief Pain Inventory -Short Form - : Improvement by greater than or equal to 50 percent: Sum of Pain Intensity Difference
Brief Pain Inventory - Short Form - : Score of greater than or equal to 50 percent: Relief from treatment
Brief Pain Inventory - Short Form- : Improvement by greater than or equal to 50 percent: Pain Interference
IP Feedback Questionnaire - IPFBQ - : Total score of greater than or equal to 20
|
Brief Pain Inventory - Short Form - : Day 1, Day 30
IP Feedback Questionnaire - IPFBQ - : Day 30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/07/2021 |
| Date of Study Completion (India) |
21/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study
Design : An Open label, Prospective, Randomised, Comparative, Two Arm
Clinical Study
Indication: Musculoskeletal
Pain
Investigational
Product: Ortho21 Oil
Comparator: None
Dose/Dosage: Treatment Arm I: Once a day, take a
small quantity of Ortho21 and massage gently topically on the area with pain.
Do not apply bandage on the top.
Treatment
Arm II: Twice a day, once in the morning and once in the night, take a
small quantity of Ortho21 and massage gently topically on the area with pain.
Do not apply bandage on top.
Subject
Population: Adult Subjects between the ages 21 and 65
years (Both ages and all genders inclusive) with chronic pain attributed to
arthritis and or acute pains such as sprains, muscle aches.
Number of
Subjects: 40 Evaluable Subjects
Treatment
Arms: Two Treatment Arms
Treatment Arm I: 23 Subjects: IP on OD Treatment
Treatment Arm II: 23 Subjects: IP on BD Treatment
Treatment
Duration: 01 Month per enrolled subject
Assessments:
Numeric Pain Rating Scale: Day
1
Brief Pain Inventory - Short Form - : Day 1, Day 30
IP Feedback Questionnaire: Day 30
Background
of the study: Musculoskeletal pain is a major reason for consultation in primary care.
The increasing prevalence of musculoskeletal pain, including back pain, has
been described as an epidemic. Pain is normally treated with oral non-steroidal
anti-inflammatory agents and opioids. These drugs deliver their beneficial
effects along with certain side effects. Use of topical pain relievers has the
potential to save many lives, decrease medical costs and improve therapy.
Purpose
of the Study: Ortho21 oil contains many a novel ingredients that synergistically
combine with each other to offer tangible relief from pain. This clinical study
is done evaluate the safety, efficacy and tolerability of Ortho21 oil as a
topical treatment for relief from acute and chronic musculoskeletal pain in
adults.
Results
of the Study
Brief
Pain Inventory : Pain Intensity :
Ortho21 OD : Acute Pain: Mean Reduction in Pain Intensity is
93% (t = 74.62, p = 0.000 < 0.05)
Ortho21 BD : Acute Pain: Mean Reduction in Pain Intensity is 99% (t =
51.50, p = 0.000 < 0.05)
Ortho21 OD : Chronic Pain: Mean Reduction in Pain Intensity is 91% (t
= 119.96, p = 0.000 < 0.05)
Ortho21 BD : Chronic Pain: Mean Reduction in Pain Intensity is 96% (t
= 95.66, p = 0.000 < 0.05).
Ortho21 Once a Day : Mean Reduction in Pain Intensity is 92% (t =
95.32, p = 0.000 < 0.05).
Ortho21 Twice a Day: Mean Reduction in Pain Intensity is 97% (t =
95.73, p = 0.000 < 0.05).
Brief Pain Inventory : Pain
Interference
Ortho21 OD : Acute Pain: Mean Reduction in Pain Intereference is
94% (t = 35.31, p = 0.000 < 0.05).
Ortho21 BD : Acute Pain: Mean Reduction in Pain Intereference is
98% (t = 1259.12, p = 0.000 < 0.05).
Ortho21 OD : Chronic Pain: Mean Reduction in Pain Intereference is
92% (t = 47.69, p = 0.000 < 0.05).
Ortho21 BD : Chronic Pain: Mean Reduction in Pain Intereference is
96% (t = 54.80, p = 0.000 < 0.05).
Ortho21 Once a Day : Mean Reduction in Pain Intereference is 93% (t =
59.25, p = 0.000 < 0.05).
Ortho21 Twice a Day: Mean Reduction in Pain Intereference is 96% (t =
62.08, p = 0.000 < 0.05).
Brief
Pain Inventory : Relief from Treatment
Ortho21 OD : Acute Pain: Mean Reduction in Relief from Treatment is
64% (t = 7.07, p = 0.000 < 0.05).
Ortho21 BD : Acute Pain: Mean Reduction in Relief from Treatment is
90% (t = 1, p = 0.000 < 0.05).
Ortho21 OD : Chronic Pain: Mean Reduction in Relief from Treatment is
63% (t = 9.38, p = 0.000 < 0.05).
Ortho21 BD : Chronic Pain: Mean Reduction in Relief from Treatment is
81% (t = 19.51, p = 0.000 < 0.05).
Ortho21 Once a Day : Mean Reduction in Relief from Treatment is
64% (t = 12.04, p = 0.000 < 0.05).
Ortho21 Twice a Day: Mean Reduction in Relief from Treatment is
82% (t = 21.19, p = 0.000 < 0.05).
Subject
IP Feedback Questionnaire
Convenience of using Ortho21: 100% of subjects marked this
5/5. (Z = 6.32, p = 0.000 < 0.05)
Response time of Ortho21: 67.5% of subjects marked this 5/5. (Z =
2.21, p = 0.000 < 0.05)
Quality of Ortho21 : 50% of subjects marked this 5/5. (Z =
0.00, p = 0.50 > 0.05).
Recommend Ortho21 to others: 100% of subjects marked this 5/5. (Z =
6.32, p = 0.000 < 0.05).
Overall satisfaction with Ortho21: 100% of subjects marked this
5/5. (Z = 6.32, p = 0.000 < 0.05).
Total Score : SIPFBQ : Mean score was 24.18 out of 25. (t = 33.82, p
= 0.000 < 0.05).
Safety
and Tolerability
Only 3 adverse reports were reported. All 3 were not related to the
investigational product.
Use of
SOS Medication
No subject reported use of SOS analgesic medication, during the course
of the 30 day treatment period.
Hence,
upon statistical analysis of the clinical study, Ortho21 Advanced Oil is
recommended as a safety therapy for use both once and twice a day for relief
from acute and chronic musculoskeletal pain.
Ortho21 Advanced Oil is recommended as a safe and effective therapy for
excellent relief from musculoskeletal pain
|