| CTRI Number |
CTRI/2022/07/044494 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
03/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on Joint health subjects |
Scientific Title of Study
Modification(s)
|
A prospective, open label study to evaluate the safety, efficacy of KAL-HS-01 in Reducing Symptoms of arthritis (Sandhigata Vata) and in maintaining Optimal Joint Health |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KAL/JH/001-22 Version 1.0 dated 01 July 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Jayantrao Raichur |
| Designation |
Principal investigator |
| Affiliation |
Kerala Ayurveda Wellness Center |
| Address |
#573 20th Main Road, next to BIBA showroom, Koramangala 8th Block, Koramangala, Bengaluru, Karnataka
Bangalore
KARNATAKA
5600095
India |
| Phone |
9880866668 |
| Fax |
|
| Email |
dranjali@keralaayurveda.biz |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarala Samuel |
| Designation |
Vice president -Research and Development |
| Affiliation |
Kerala Ayurveda Ltd. |
| Address |
Athani Post, Aluva,
Ernakulam District, Kerala – India
Bangalore
KARNATAKA
683585
India |
| Phone |
9895517764 |
| Fax |
|
| Email |
sarala@keralaayurveda.biz |
|
Details of Contact Person
Public Query
|
| Name |
DrSarala Samuel |
| Designation |
Vice president -Research and Development |
| Affiliation |
Kerala Ayurveda Ltd. |
| Address |
Athani Post, Aluva,
Ernakulam District, Kerala – India
KARNATAKA
683585
India |
| Phone |
9895517764 |
| Fax |
|
| Email |
sarala@keralaayurveda.biz |
|
|
Source of Monetary or Material Support
|
| Kerala Ayurveda Limited
Athani Post, Aluva,Ernakulam District, Kerala – 683585, India
|
|
|
Primary Sponsor
|
| Name |
Kerala Ayurveda Limited |
| Address |
Athani Post, Aluva,Ernakulam District, Kerala – 683585, India |
| Type of Sponsor |
Other [Ayurveda and wellness ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Jayantrao Raichur |
Kerala Ayurveda Wellness Center |
#573 20th Main Road, Ground floor room number 2 next to BIBA showroom, Koramangala 8th Block, Koramangala, Bengaluru, Karnataka 5600095
Bangalore
KARNATAKA |
9880866668
dranjali@keralaayurveda.biz |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospitals Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M180||Bilateral primary osteoarthritis of first carpometacarpal joints. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KAL-HS-01 Arishtam |
Dosage : Arishtam
Dose: 60 ml per day (Morning 30 ml and evening 30 ml after food)
Duration: 8 weeks
|
| Comparator Agent |
Nil (Open label study) |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to give informed consent.
2. Healthy Indian male/ female volunteer aged between 18-65 years.
3. Must be able to adhere to the study visit schedule and other protocol requirements.
4. Willing to complete the questionnaires for the total duration of 45 days.
5. Joint and muscle pain in the last 1 month.
6. Willing to avoid usage of pain relievers like Ibuprofen, Acetaminophen or any other NSAIDs etc. during the study duration.
7. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or Breast feeding.
2. Inability to provide voluntary consent
3. Patients with pre existing severe systemic disease like uncontrolled diabetes hypertension Cardiac illness etc necessitating long term medication
4. Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation
5. Any clinically significant medical history medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol
6. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
7. Use of any anti psychotic drugs for one week prior to Baseline
8. Subjects who abuse drugs or alcohol drug screening not required
9. Use of any investigational medication within 4 weeks prior to start of study drug.
10. Greater than moderate alcohol use
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy/ perceived benefit of JOINT CARE in the following:
1. RHEUMATIC PAIN
2. JOINT SWELLING
3. MUSCLE PAIN
4. JOINT & MUSCLE STIFFNESS.
• % Improvement in the knee pain assessed through VAS [Time: Day 0 to Day 56]
• % Change in the joint swelling assessed by the Investigator [Time: Day 0 to Day 56]
|
Day 0 to Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• % Improvement in the muscle pain assessed through VAS [Time: Day 0 to Day 56]
• % Improvement in the joint and muscle stiffness assessed by the investigator [Time: Day 0 to Day 56]
|
Day 0 to Day 56 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/08/2022 |
| Date of Study Completion (India) |
20/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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
|
Kerala
ayurveda R&D team has developed unique formulation for RHEUMATIC PAIN, JOINT
SWELLING, MUSCLE PAIN and JOINT & MUSCLE STIFFNESS.
Non-steroidal
anti-inflammatory drugs (NSAIDs) are the most commonly used drugs for the
symptomatic treatment of pain in OA. However, NSAIDs are associated with
serious gastrointestinal adverse effects which limit their use in many patients
. Other drugs like opioids and non-opioid analgesics and intra-articular
steroids may not be effective in all patients Hence, there is a specific need
for effective and safe drugs in the treatment of OA.
Herbal medicines have
been explored for their usefulness in OA for a long time. Osteoarthritis, also
known as degenerative joint disease (DJD), is the most common type of
arthritis. leaves of Woodfordia fruticosa afford anti-inflammatory activity by
preventing the inflammation in different animal models.Aqueous extract of Withania
somnifera produced significant reduction in 60 knee joint pain
patients.
A few medicinal herbs
have a place to mention in the ayurvedic books for their individual anti-inflammatory
activity. The present study is aimed to see a combination of a few such herbal
medicinal plants for their efficacy in knee pain and joint health |