Knee Osteoarthritis (Knee OA)NCT04833946
To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint.
A study testing Andrographis paniculata [150 mg] and Microcrystalline Cellulose (MCC) in people with Knee Osteoarthritis (Knee OA), run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Andrographis paniculata [150 mg] and Microcrystalline Cellulose (MCC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 5 sitesIndia
- Study dates
- 13 Mar 2021to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Jaipur National University Institute for Medical Sciences and Research Center
Jaipur, Rajasthan, 302017
Asopa Hospital
Jaipur, Rajasthan, 30201
Ayush Nursing Home
Mumbai, Maharashtra, 400067
New Healthcare Nursing Home
Thane, Maharashtra, 401107
Shubham Sudbhawana Super Specialty Hospital
Varanasi, Uttar Pradesh, 221005
About this study
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.
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
Read the 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.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Andrographis paniculata [150 mg], Microcrystalline Cellulose (MCC)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andrographis paniculata [150 mg]Other
One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime
Microcrystalline Cellulose (MCC)Other
One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Andrographis paniculata [150 mg] | Active comparator | One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime Receives: Other: Andrographis paniculata [150 mg] |
| Microcrystalline Cellulose (MCC) | Placebo comparator | One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime Receives: Other: Microcrystalline Cellulose (MCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0 and day 336
Secondary outcomes (6)
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)
Measured: day 0, 28, 84, 140, 168, 252 and day 336
Cartilage thickness at femur, tibia and patella compartments
Change in cartilage thickness at the femur, tibia and patella compartments as assessed by MRI
Measured: Day 0 and day 336
Outcome Measures in Arthritis Clinical Trials OA Research Society International
Treatment responders as assessed by OMERACT-OARSI in comparison to placebo
Measured: day 336
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
Measured: Day 0 and day 336
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
Measured: Day 0 and day 336
Change in the Quality of Life
Change in Quality of life as assessed by using Short Form-36
Measured: Day 0, 84, 168, and day 336
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start13 Mar 2021
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833946
- Sponsor's protocol ID
- IN/201001/PARACTIN/OA
- Status last verified
- May 2025
- First submitted
- 3 Apr 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04833946
- Acronym / sponsor ID
- IN/201001/PARACTIN/OA
- Conditions
- Knee Osteoarthritis (Knee OA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2021 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Andrographis paniculata [150 mg] | Active comparator | Other: Andrographis paniculata [150 mg]One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime |
| Microcrystalline Cellulose (MCC) | Placebo comparator | Other: Microcrystalline Cellulose (MCC)One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- Radiographic evidence of grade II- III knee OA based on the Kellgren and Lawrence (KL) radiographic entry criteria for OA.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andrographis paniculata [150 mg]One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime | Other | Andrographis paniculata [150 mg] |
| Microcrystalline Cellulose (MCC)One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime | Other | Microcrystalline Cellulose (MCC) |
Primary outcome
Joint Space Narrowing as assessed by magnetic resonance imaging
Time frame: Day 0 and day 336
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)
6 secondary outcomes
Modified Western Ontario and McMaster Universities Pain and total scores
Time frame: day 0, 28, 84, 140, 168, 252 and day 336
Cartilage thickness at femur, tibia and patella compartments
Time frame: Day 0 and day 336
Outcome Measures in Arthritis Clinical Trials OA Research Society International
Time frame: day 336
Bone turnover (by measuring bone specific alkaline phosphatase levels)
Time frame: Day 0 and day 336
Cartilage turnover as assessed by Cartilage Oligomeric matrix protein (COMP)
Time frame: Day 0 and day 336
Change in the Quality of Life
Time frame: Day 0, 84, 168, and day 336
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Andrographis paniculata [150 mg] and Microcrystalline Cellulose (MCC) in people with Knee Osteoarthritis (Knee OA), run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Space Narrowing as assessed by magnetic resonance imaging (time frame: Day 0 and day 336). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.