Clinical Study on â€œOrtho21â€ of OnTop Vedics as a Pain Relief Oil.

Phase 3

Completed

Conditions: Pain in joint. Ayurveda Condition: SANDHIGATAVATAH,

Registration Number: CTRI/2021/07/034690

Lead Sponsor: OnTop Vedics A Division of OnTop Pharmaceuticals

Brief Summary: **StudyDesign** : An Open label, Prospective, Randomised, Comparative, Two ArmClinical Study

**Indication:** MusculoskeletalPain

**InvestigationalProduct:** Ortho21 Oil

**Comparator:** None

**Dose/Dosage:** Treatment Arm I: Once a day, take asmall quantity of Ortho21 and massage gently topically on the area with pain.Do not apply bandage on the top.

**TreatmentArm II:** Twice a day, once in the morning and once in the night, take asmall quantity of Ortho21 and massage gently topically on the area with pain.Do not apply bandage on top.

**SubjectPopulation:** Adult Subjects between the ages 21 and 65years (Both ages and all genders inclusive) with chronic pain attributed toarthritis and or acute pains such as sprains, muscle aches.

**Number ofSubjects:** 40 Evaluable Subjects

**TreatmentArms: Two Treatment Arms** **Treatment Arm I:** 23 Subjects: IP on OD Treatment **Treatment Arm II:** 23 Subjects: IP on BD Treatment

**TreatmentDuration:** 01 Month per enrolled subject

**Assessments:** Numeric Pain Rating Scale: Day1 Brief Pain Inventory - Short Form - : Day 1, Day 30 IP Feedback Questionnaire: Day 30

**Backgroundof the study:** Musculoskeletal pain is a major reason for consultation in primary care.The increasing prevalence of musculoskeletal pain, including back pain, hasbeen described as an epidemic. Pain is normally treated with oral non-steroidalanti-inflammatory agents and opioids. These drugs deliver their beneficialeffects along with certain side effects. Use of topical pain relievers has thepotential to save many lives, decrease medical costs and improve therapy.

**Purposeof the Study:** Ortho21 oil contains many a novel ingredients that synergisticallycombine with each other to offer tangible relief from pain. This clinical studyis done evaluate the safety, efficacy and tolerability of Ortho21 oil as atopical treatment for relief from acute and chronic musculoskeletal pain inadults.

Resultsof the Study

**Brief Pain Inventory : Pain Intensity :** Ortho21 OD : Acute Pain: Mean Reduction in Pain Intensity is93% (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 : PainInterference** Ortho21 OD : Acute Pain: Mean Reduction in Pain Intereference is94% (t = 35.31, p = 0.000 < 0.05). Ortho21 BD : Acute Pain: Mean Reduction in Pain Intereference is98% (t = 1259.12, p = 0.000 < 0.05). Ortho21 OD : Chronic Pain: Mean Reduction in Pain Intereference is92% (t = 47.69, p = 0.000 < 0.05). Ortho21 BD : Chronic Pain: Mean Reduction in Pain Intereference is96% (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).

**BriefPain Inventory : Relief from Treatment** Ortho21 OD : Acute Pain: Mean Reduction in Relief from Treatment is64% (t = 7.07, p = 0.000 < 0.05). Ortho21 BD : Acute Pain: Mean Reduction in Relief from Treatment is90% (t = 1, p = 0.000 < 0.05). Ortho21 OD : Chronic Pain: Mean Reduction in Relief from Treatment is63% (t = 9.38, p = 0.000 < 0.05). Ortho21 BD : Chronic Pain: Mean Reduction in Relief from Treatment is81% (t = 19.51, p = 0.000 < 0.05). Ortho21 Once a Day : Mean Reduction in Relief from Treatment is64% (t = 12.04, p = 0.000 < 0.05). Ortho21 Twice a Day: Mean Reduction in Relief from Treatment is82% (t = 21.19, p = 0.000 < 0.05).

**SubjectIP Feedback Questionnaire** Convenience of using Ortho21: 100% of subjects marked this5/5. (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 this5/5. (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).

**Safetyand Tolerability** Only 3 adverse reports were reported. All 3 were not related to theinvestigational product.

**Use ofSOS Medication** No subject reported use of SOS analgesic medication, during the courseof the 30 day treatment period.

**Hence,upon statistical analysis of the clinical study, Ortho21 Advanced Oil isrecommended as a safety therapy for use both once and twice a day for relieffrom acute and chronic musculoskeletal pain. Ortho21 Advanced Oil is recommended as a safe and effective therapy forexcellent relief from musculoskeletal pain**

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.
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.
Subjects who are willing to abstain from use of any topical ointment, cream etc that are indicated for mitigating pain and aches.
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.
Subject who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory -Short Form - : Improvement by greater than or equal to 50 percent: Sum of Pain Intensity Difference	Brief Pain Inventory - Short Form - : Day 1, Day 30 \| IP Feedback Questionnaire - IPFBQ - : Day 30
Brief Pain Inventory - Short Form - : Score of greater than or equal to 50 percent: Relief from treatment	Brief Pain Inventory - Short Form - : Day 1, Day 30 \| IP Feedback Questionnaire - IPFBQ - : Day 30
Brief Pain Inventory - Short Form- : Improvement by greater than or equal to 50 percent: Pain Interference	Brief Pain Inventory - Short Form - : Day 1, Day 30 \| IP Feedback Questionnaire - IPFBQ - : Day 30
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 Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1): Raam Clinic
🇮🇳
Chennai, TAMIL NADU, India
Raam Clinic
🇮🇳Chennai, TAMIL NADU, India
Dr VT Sriraam
Principal investigator
9840909155
md@auroushealthcare.com