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To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint.

Primary Purpose

Knee Osteoarthritis (Knee OA)

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Andrographis paniculata [150 mg]
Microcrystalline Cellulose (MCC)
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis (Knee OA)

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male and female Patients aged ≥40 and ≤85 years.
  2. Patients with a history of clinically symptomatic OA of the knee for ≥ 6 months.
  3. Index knee joint pain rated ≥60 mm on a 100 point Pain Visual Analogue Scale (VAS).
  4. Patient must have a diagnosis of idiopathic OA according to the American College of Rheumatology clinical and radiographic criteria with knee pain, osteophytes, and fulfilment of at least 2 of the 3 criteria:

    • Age of ≥50 years Stiffness lasting <30 minutes after getting up in the morning
    • Crepitus
  5. Radiographic evidence of grade II- III knee OA based on the Kellgren and Lawrence (KL) radiographic entry criteria for OA.

    • Grade II: - Definite osteophytes and possible joint space narrowing (JSN) on the anteroposterior weight-bearing radiograph.
    • Grade III: Anteroposterior weight-bearing knee radiograph demonstrates definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends.
  6. Patients with normal liver & renal function defined as:

    • Serum Alkaline phosphatase levels up to 1.5 of ULN (Upper Limit of Normal).
    • Serum AST and ALT levels up to 2.5 of ULN.
    • Serum creatinine levels up to 1.5 of ULN.
    • Blood Urea Nitrogen levels up to 1.5 of ULN.
  7. Female Patients must not be of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy])
  8. Patients must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting from the screening visit until completing participation in the study.
  9. Abstinence from any home-based remedies or any other form of topical products intended for knee joint pain relief for the entire study duration.
  10. Patient must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting routine) for the duration of the study starting from the screening visit.
  11. Ability to read and provide written, personally signed, and dated informed consent to participate in the study.
  12. An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Exclusion Criteria:

  1. Patients who have any contraindications to MRI, such as, but not limit to:A metal device affected by MRI (e.g. any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted cardiac defibrillator); - Have history of orbit trauma by a potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) for which they sought medical attention; - Have claustrophobia; - Have difficulty fitting into the MRI knee coil due to greater than normal thigh diameter.
  2. Any other lower limb dis-functionality of lower limb other than the knee that, in the opinion of the Investigator, could interfere with pain and functional assessments related to the knee.
  3. Patients who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee.
  4. Patients who has had significant injury, as judged by the Investigator, involving the target knee within the 6 months before screening.
  5. Patients who has used opiates or corticosteroids within 30 days before screening for the target knee or who requires treatment with chronic opiates or corticosteroids or had intra articular injections of corticosteroids, hyaluronic acid, or visco supplements to a knee to be treated within the 3 months before Screening.
  6. Patients who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen.
  7. Known sensitivity to the investigational product or any excipients of the drug product.
  8. Patients who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, or other conditions that may affect the target joint or the functional and pain assessments (eg, osteonecrosis, chondrocalcinosis).
  9. Patients has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease, or any other condition that, in the investigator's opinion, could compromise the Patient's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
  10. Patients has any other clinically significant laboratory finding at screening that in the investigator's opinion contraindicates study participation.
  11. Presence of uncontrolled hypertension (Defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg).
  12. Uncontrolled diabetes defined as fasting blood glucose (FBG) > 125 mg/dL.
  13. Patients with heavy alcohol consumption, defined as - For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day. - For women: More than 7 SAD/week or more than 3 SAD in a day.

    (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).

  14. Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a 2-hour time frame.
  15. Individuals having a history (in past 2 years) of smoking or currently smoking or using any form of smokeless tobacco.
  16. Patients without access to telephone and/or ability to gain technology access.
  17. Patients who participated in another human trial within last 90 days prior to screening.
  18. Any condition that could, in the opinion of the investigator, preclude the Patient's ability to successfully and safely complete the study or that may confound study outcomes.

Sites / Locations

  • Ayush Nursing Home
  • New Healthcare Nursing Home
  • Jaipur National University Institute for Medical Sciences and Research CenterRecruiting
  • Asopa Hospital
  • Shubham Sudbhawana Super Specialty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Andrographis paniculata [150 mg]

Microcrystalline Cellulose (MCC)

Arm Description

One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime

One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime

Outcomes

Primary Outcome Measures

Joint Space Narrowing as assessed by magnetic resonance imaging
to evaluate the effect of 336 days of IP consumption on change in joint space narrowing (JSN) in the tibiofemoral joint of knee as measured by magnetic resonance imaging (MRI)

Secondary Outcome Measures

Modified Western Ontario and McMaster Universities Pain and total scores
Patients rate their pain, stiffness, or physical function using five ordinal responses: none, mild, moderate, severe, and extreme..Change in knee joint pain as assessed by the Western Ontario and McMaster University Arthritis Index pain subscale (mWOMAC -P)
Cartilage thickness at femur, tibia and patella compartments
Change in cartilage thickness at the femur, tibia and patella compartments as assessed by MRI
Outcome Measures in Arthritis Clinical Trials OA Research Society International
Treatment responders as assessed by OMERACT-OARSI in comparison to placebo
Bone turnover (by measuring bone specific alkaline phosphatase levels)
Change in bone turnover as assessed by change in serum levels of bone specific alkaline phosphatase
Cartilage turnover as assessed by Cartilage Oligomeric matrix protein (COMP)
Change in cartilage turnover as assessed by change in serum levels of cartilage oligomeric matrix protein
Change in the Quality of Life
Change in Quality of life as assessed by using Short Form-36

Full Information

First Posted
April 3, 2021
Last Updated
November 29, 2022
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04833946
Brief Title
To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint.
Official Title
A Double-blind, Randomized, Placebo-controlled Study to Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sponsor aimed to study hydroalcoholic extract of Andrographis paniculata (for its effect on OA disease progression in OA patients with moderate to severe knee OA. Hydroalcoholic extract of Andrographis paniculata (standardized for 50% bioactive andrographolides).Andrographis paniculata may have an effect on increasing the expression of collagen type II protein and also mitigate the migration of inflammatory cells or angiogenesis
Detailed Description
Sponsor aimed to study hydroalcoholic extract of Andrographis paniculata (for its effect on OA disease progression in OA patients with moderate to severe knee OA. Hydroalcoholic extract of Andrographis paniculata (standardized for 50% bioactive andrographolides). It has been evaluated in clinical studies for its anti-inflammatory and anti-oxidant activities. Although the potential cartilage regenerative mechanism of Andrographis paniculata is unknown, Sponsor believe that Andrographis paniculata may have an effect on increasing the expression of collagen type II protein and also mitigate the migration of inflammatory cells or angiogenesis. In the present study, knee morphometrics (joint space narrowing of tibiofemoral joint, and cartilage thickness at the femur, tibia and patella compartments), cartilage turnover (serum COMP levels), bone turnover (serum Bone specific alkaline phosphatase) along with symptomatic relief (Using mWOMAC) in patients with primary knee OA over a period of 336 days will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis (Knee OA)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Andrographis paniculata [150 mg]
Arm Type
Active Comparator
Arm Description
One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime
Arm Title
Microcrystalline Cellulose (MCC)
Arm Type
Placebo Comparator
Arm Description
One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime
Intervention Type
Other
Intervention Name(s)
Andrographis paniculata [150 mg]
Intervention Description
One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime
Intervention Type
Other
Intervention Name(s)
Microcrystalline Cellulose (MCC)
Intervention Description
One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime
Primary Outcome Measure Information:
Title
Joint Space Narrowing as assessed by magnetic resonance imaging
Description
to evaluate the effect of 336 days of IP consumption on change in joint space narrowing (JSN) in the tibiofemoral joint of knee as measured by magnetic resonance imaging (MRI)
Time Frame
Day 0 and day 336
Secondary Outcome Measure Information:
Title
Modified Western Ontario and McMaster Universities Pain and total scores
Description
Patients rate their pain, stiffness, or physical function using five ordinal responses: none, mild, moderate, severe, and extreme..Change in knee joint pain as assessed by the Western Ontario and McMaster University Arthritis Index pain subscale (mWOMAC -P)
Time Frame
day 0, 28, 84, 140, 168, 252 and day 336
Title
Cartilage thickness at femur, tibia and patella compartments
Description
Change in cartilage thickness at the femur, tibia and patella compartments as assessed by MRI
Time Frame
Day 0 and day 336
Title
Outcome Measures in Arthritis Clinical Trials OA Research Society International
Description
Treatment responders as assessed by OMERACT-OARSI in comparison to placebo
Time Frame
day 336
Title
Bone turnover (by measuring bone specific alkaline phosphatase levels)
Description
Change in bone turnover as assessed by change in serum levels of bone specific alkaline phosphatase
Time Frame
Day 0 and day 336
Title
Cartilage turnover as assessed by Cartilage Oligomeric matrix protein (COMP)
Description
Change in cartilage turnover as assessed by change in serum levels of cartilage oligomeric matrix protein
Time Frame
Day 0 and day 336
Title
Change in the Quality of Life
Description
Change in Quality of life as assessed by using Short Form-36
Time Frame
Day 0, 84, 168, and day 336

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female Patients aged ≥40 and ≤85 years. Patients with a history of clinically symptomatic OA of the knee for ≥ 6 months. Index knee joint pain rated ≥60 mm on a 100 point Pain Visual Analogue Scale (VAS). Patient must have a diagnosis of idiopathic OA according to the American College of Rheumatology clinical and radiographic criteria with knee pain, osteophytes, and fulfilment of at least 2 of the 3 criteria: Age of ≥50 years Stiffness lasting <30 minutes after getting up in the morning Crepitus Radiographic evidence of grade II- III knee OA based on the Kellgren and Lawrence (KL) radiographic entry criteria for OA. Grade II: - Definite osteophytes and possible joint space narrowing (JSN) on the anteroposterior weight-bearing radiograph. Grade III: Anteroposterior weight-bearing knee radiograph demonstrates definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends. Patients with normal liver & renal function defined as: Serum Alkaline phosphatase levels up to 1.5 of ULN (Upper Limit of Normal). Serum AST and ALT levels up to 2.5 of ULN. Serum creatinine levels up to 1.5 of ULN. Blood Urea Nitrogen levels up to 1.5 of ULN. Female Patients must not be of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) Patients must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting from the screening visit until completing participation in the study. Abstinence from any home-based remedies or any other form of topical products intended for knee joint pain relief for the entire study duration. Patient must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting routine) for the duration of the study starting from the screening visit. Ability to read and provide written, personally signed, and dated informed consent to participate in the study. An understanding, ability, and willingness to fully comply with study procedures and restrictions. Exclusion Criteria: Patients who have any contraindications to MRI, such as, but not limit to:A metal device affected by MRI (e.g. any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted cardiac defibrillator); - Have history of orbit trauma by a potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) for which they sought medical attention; - Have claustrophobia; - Have difficulty fitting into the MRI knee coil due to greater than normal thigh diameter. Any other lower limb dis-functionality of lower limb other than the knee that, in the opinion of the Investigator, could interfere with pain and functional assessments related to the knee. Patients who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee. Patients who has had significant injury, as judged by the Investigator, involving the target knee within the 6 months before screening. Patients who has used opiates or corticosteroids within 30 days before screening for the target knee or who requires treatment with chronic opiates or corticosteroids or had intra articular injections of corticosteroids, hyaluronic acid, or visco supplements to a knee to be treated within the 3 months before Screening. Patients who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen. Known sensitivity to the investigational product or any excipients of the drug product. Patients who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, or other conditions that may affect the target joint or the functional and pain assessments (eg, osteonecrosis, chondrocalcinosis). Patients has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease, or any other condition that, in the investigator's opinion, could compromise the Patient's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation. Patients has any other clinically significant laboratory finding at screening that in the investigator's opinion contraindicates study participation. Presence of uncontrolled hypertension (Defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg). Uncontrolled diabetes defined as fasting blood glucose (FBG) > 125 mg/dL. Patients with heavy alcohol consumption, defined as - For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day. - For women: More than 7 SAD/week or more than 3 SAD in a day. (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol). Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a 2-hour time frame. Individuals having a history (in past 2 years) of smoking or currently smoking or using any form of smokeless tobacco. Patients without access to telephone and/or ability to gain technology access. Patients who participated in another human trial within last 90 days prior to screening. Any condition that could, in the opinion of the investigator, preclude the Patient's ability to successfully and safely complete the study or that may confound study outcomes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Shalini Srivastava, MD - Md
Phone
02242172325
Email
shalini.s@vediclifesciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Sonali Ghosh, BAMS
Phone
8097572024
Email
sonali.g@vediclifesciences.com
Facility Information:
Facility Name
Ayush Nursing Home
City
Mumbai-
State/Province
Maharashtra
ZIP/Postal Code
400067
Country
India
Individual Site Status
Active, not recruiting
Facility Name
New Healthcare Nursing Home
City
Thāne
State/Province
Maharashtra
ZIP/Postal Code
401107
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Jaipur National University Institute for Medical Sciences and Research Center
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Shrinivas Yadkikar, MBBS, MS Ortho
Phone
9902097190
Email
advisoroffice@jnujaipur.ac.in
First Name & Middle Initial & Last Name & Degree
Dr. Shrinivas Yadkikar, MBBS, MS Ortho
Facility Name
Asopa Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
30201
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Arwind Asopa, MS Ortho
Phone
9829013481
Email
dr.asopa@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Arwind Asopa, MS Ortho
Facility Name
Shubham Sudbhawana Super Specialty Hospital
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221005
Country
India
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint.

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