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

NCT04833946 | Completed

• 1 other identifier: IN/201001/PARACTIN/OA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

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

Conditions

Knee Osteoarthritis (Knee OA)

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 0 and day 336

Secondary Outcomes (6)

• Modified Western Ontario and McMaster Universities Pain and total scores

  day 0, 28, 84, 140, 168, 252 and day 336

• Cartilage thickness at femur, tibia and patella compartments

  Day 0 and day 336

• Outcome Measures in Arthritis Clinical Trials OA Research Society International

  day 336

• Bone turnover (by measuring bone specific alkaline phosphatase levels)

  Day 0 and day 336

• Cartilage turnover as assessed by Cartilage Oligomeric matrix protein (COMP)

  Day 0 and day 336

Study Arms (2)

Andrographis paniculata [150 mg]

ACTIVE COMPARATOR

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

Other: Andrographis paniculata [150 mg]

Microcrystalline Cellulose (MCC)

PLACEBO COMPARATOR

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

Other: Microcrystalline Cellulose (MCC)

Interventions

Andrographis paniculata [150 mg] OTHER

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

Andrographis paniculata [150 mg]

Microcrystalline Cellulose (MCC) OTHER

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

Microcrystalline Cellulose (MCC)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\])

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (5)

Ayush Nursing Home

Mumbai, Maharashtra, 400067, India

Location

New Healthcare Nursing Home

Thane, Maharashtra, 401107, India

Location

Jaipur National University Institute for Medical Sciences and Research Center

Jaipur, Rajasthan, 302017, India

Location

Asopa Hospital

Jaipur, Rajasthan, 30201, India

Location

Shubham Sudbhawana Super Specialty Hospital

Varanasi, Uttar Pradesh, 221005, India

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Andrographis paniculata extract; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 6, 2021
• Study Start: March 13, 2021
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

IN (5)