CTRI

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CTRI Number

CTRI/2024/04/065669 [Registered on: 15/04/2024] Trial Registered Prospectively

Last Modified On:

02/04/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Non-randomized, Multiple Arm Trial

Public Title of Study

Use of Amrutanjan Advanced Ortho Pain Relief + Oil in arthritis patients

Scientific Title of Study

A Randomized, Open label, Clinical study to evaluate the efficacy and safety of Amrutanjan Advanced Ortho Pain Relief + Oil in osteoarthritis and Rheumatoid arthritis patients

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
AKOIL/02/24, Version 1.1 dated 23.02.2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr M Sakthi Balan MD
Designation	Consultant and CI
Affiliation	Ki3 Pvt Ltd
Address	Room 1, Medicine OPD, Thirumalai Medical Centre, Cuddalore main road, Pondicherry Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai Pondicherry PONDICHERRY 605004 India
Phone	9443627722
Fax
Email	saheerose@gmail.com

Details of Contact Person
Scientific Query

Name	Dr M Sakthi Balan MD
Designation	Consultant and CI
Affiliation	Ki3 Pvt Ltd
Address	Room 1, Medicine OPD, Thirumalai Medical Centre, Cuddalore main road, Pondicherry Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai PONDICHERRY 605004 India
Phone	9443627722
Fax
Email	saheerose@gmail.com

Details of Contact Person
Public Query

Name	Dr Gayathri Sivakumar
Designation	Director
Affiliation	Ki3 Pvt Ltd
Address	Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai Chennai TAMIL NADU 600032 India
Phone	9003109416
Fax
Email	drgayathri@ki3services.com

Source of Monetary or Material Support

Amrutanjan Health Care Limited, Tamil Nadu, India

Primary Sponsor

Name	Amrutanjan Health Care Limited, Tamil Nadu, India
Address	Mylapore Chennai 600004
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Chandrashekar MBBS MS	Kumaran Multi-specialty Hospital	Room no.4, Ortho OP,Kumaran Multi-specialty Hospital, No 1, 2nd Cross St, Sithananda Nagar, Thanthai Periyar Nagar, Ellapillaichavady, Puducherry 605005 Pondicherry PONDICHERRY	9443398534 drchandrasekarortho@gmail.com
Dr M Sakthi Balan	Thirumalai Medical Centre, Puducherry	Room no.1: Medicine OPD, Thirumalai Medical Centre Pondicherry PONDICHERRY	9443627722 saheerose@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
Ethique De La Nature Association	Approved
Ethique De La Nature Association	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M179\|\|Osteoarthritis of knee, unspecified,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Amrutanjan advanced ortho pain relief + oil, Reference: Nil, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: -), Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria and confirmed with X-rays and with grade I and II as per Kellgren and Lawrence classification system and patients previously diagnosed with Rheumatoid arthritis (grade I and II) as per the American Rheumatism Association. 2. Have been on stable dose of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS) and other treatments for a minimum period of 3 months in the past. 3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS) 4. Patient should have not participated in any other clinical trial during the past 3 months. 5. Participants, who are willing to give written, signed and dated informed consent to participate in the study.

ExclusionCriteria

Details

1. Recent history of trauma to the knee joint.
2. Having severe pain and inflammation, which is not getting controlled on NSAIDs
3. Uncontrolled diabetic patients with Hba1C greater than 10.
4. Pregnant or lactating
5. Received any other investigational medicine within 7 days prior to screening which
can interfere with investigational product activity
6. Suffering from any illness which will interfere with present study as decided by
clinical investigator
7. History of hypersensitivity to any of the test products.
8. Any condition (like instability of knee joint, ligament tear or loose bodies in knee
joint) decided as unfit for study by Clinical investigator

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

1. Knee pain intensity measured by Pain VAS Scale ( 0- 100mm)
2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, Physical Function and Stiffness Subscale.
3. Changes in following laboratory parameters for all the patients: C Reactive Protein and ESR
Change from base line to week 8 in the RA factor for RA patients.
4. Patients Global Assessment of Osteoarthritis or Rheumatoid arthritis patients.
5. Number of Participants with a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT OARSI).
6. Quality of life Questionnaires using Short Form Health 12.
7. X ray (knee joint) will be done at Baseline and at end of 8 weeks.

Week 2, 4, 6 and 8

Secondary Outcome

Outcome	TimePoints
Safety and tolerability evaluation criteria: Adverse events and serious adverse events during the study period Laboratory (haematology and biochemistry) parameters (if any) Brief clinical examination Vital signs (pulse rate, respiratory rate, systolic and diastolic blood pressure, and body temperature)	Week 2, 4, 6 and 8

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60"

Phase of Trial

Phase 3

Date of First Enrollment (India)

20/04/2024

Date of Study Completion (India)

04/02/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="3"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

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

The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 60 participants with Osteoarthritis and Rheumatoid arthritis will be enrolled in this study in two separate arms.

The IP will be applied on the affected area three times a day for 8 weeks.

The following parameters will be monitored.

Primary end Points

1. 1. Knee pain intensity measured by Pain VAS Scale (0 to 100 mm)

2. 2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, Physical Function and Stiffness Subscale.

3. 3. Changes in following laboratory parameter(s) for all the patients: C Reactive Protein and ESR

Change from base line to week 8 in the RA factor for RA patients.

4. 4. Patients Global Assessment of Osteoarthritis or Rheumatoid arthritis patients.

5. 5. Number of Participants with a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT OARSI).

6. 6. Quality of life Questionnaires using Short Form Health 12.

7. 7. X ray (knee joint) will be done at Baseline and at end of 8 weeks.