Assessment of the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis (A Paniculata)

July 8, 2021 updated by: Vedic Lifesciences Pvt. Ltd.

A Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis Over a 12-weeks Period

This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the effect of Andrographis Paniculata at low dose of 300 mg/day and high dose of 600 mg/day in the study population in the age range of 40-70 years and suffering from mild-moderate OA.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, we will assess the efficacy parameters such as effect on various joint health parameters (pain, stiffness and physical activity) by using WOMAC scale. The individuals with knee OA suffer from an increased impact on their activities of daily living, which leads to losses in labor relations, leisure, social life, and sleeping quality, leading also to important decrease in their quality of life. Thus, an important outcome to be evaluated in this study is quality of life of these individuals which will be assessed by SF-36 self-reported questionnaire. One of the aims of this study is therefore to investigate the levels of different dimensions of fatigue in knee OA and to assess changes in fatigue after the treatment targeting pain reduction and physical functioning by the use of FACIT-fatigue questionnaire.

Effect of the treatment on rescue medication consumption which is directly proportional to the degree of pain will also be captured via this study. The hepatic (SGOT and SGPT) and renal (serum creatinine) safety biomarkers will be assessed to investigate the effect of chronic use of Andrographis Paniculata on liver and kidneys.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400031
        • Nidaan Hospital, A/1, Adinath Society, Near Dosti Estate, Opposite Antop Hill Post Office, Wadala(West)
      • Mumbai, Maharashtra, India, 400067
        • Ayush nursing Home, Gaurav vista, Gaurav Garden,BunderpakhadiRoad, Kandivali(West)
      • Mumbai, Maharashtra, India, 400706
        • Siddhant Clinic, Shop No. 17, Lenyadri Cooperative Housing Society, Sector 19A, Nerul(East),Navi Mumbai -400706, Maharashtra
      • Mumbai, Maharashtra, India
        • Orthopaedic Clinic, 213, 2nd floor, Shiv Centre, Plot no. 72, Sector-17, Vashi, Navi Mumbai.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects in the age range of 40 - 70 years (both inclusive).
  2. Body mass index (BMI) must be ≥ 25 and < 29.9 kg/m2.
  3. Radiographic evidence of grade I- II osteoarthritis of knee joint, based on the Kellgren and Lawrence radiographic entry criteria with WOMAC pain score in range of 10-16.
  4. History of primary idiopathic osteoarthritis of the knee characterized by pain of mild to moderate intensity which requires intake of analgesics.
  5. Self-reported difficulty in at least one of the following activities attributed to knee pain: walking a distance of 400 metres, getting in and out of the car, going up and down the stairs or stiffness observed in the knee if > 30 minutes in the same position.
  6. Female subjects of child-bearing age must be willing to use the accepted methods of contraception during the course of the study.
  7. Ability to provide written informed consent.

Exclusion Criteria:

  1. Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings or laboratory abnormalities that in the investigator's opinion could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed or could impair the assessment of study results.
  2. History of surgery or major trauma to the study joint.
  3. History of arthroscopic surgery or intervention on the study joint.
  4. Subjects who have received intra-articular steroids or hyaluronic acid within the last three months.
  5. Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period.
  6. Subjects awaiting a replacement of knee or hip joint.
  7. Subjects with other conditions that cause pain.
  8. Subjects with deformity of the knee joint.
  9. Subject who are significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices.
  10. Subjects with other known rheumatic or inflammatory disease such as rheumatoid arthritis, osteomyelitis and bone metastasis.
  11. Other pathologic lesions on X-rays of knee.
  12. Positive hepatitis B surface antigen, Hepatitis C antibody, Anti human immunodeficiency virus (HIV) antibody test, or VDRL.
  13. History of bleeding disorders.
  14. Inability to comply with the protocol requirements.
  15. Participation in any other clinical trial within 3 months of registering in this trial.
  16. Women of child-bearing potential with a positive pregnancy test or who are lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Microcrystalline cellulose
Dietary supplement: Placebo
Microcrystalline cellulose
Active Comparator: Andrographis Paniculata 150
Andrographis Paniculata 150 mg
Dietary supplement: Andrographis Paniculata
Andrographis Paniculata 150 mg
Dietary supplement: Andrographis Paniculata
Andrographis Paniculata 300 mg
Active Comparator: Andrographis Paniculata 300
Andrographis Paniculata 300 mg
Dietary supplement: Andrographis Paniculata
Andrographis Paniculata 150 mg
Dietary supplement: Andrographis Paniculata
Andrographis Paniculata 300 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
WOMAC pain score
Time Frame: 84 days
Change in WOMAC pain score
84 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WOMAC stiffness score
Time Frame: 84 days
Change in WOMAC stiffness score
84 days
WOMAC physical function score
Time Frame: 84 days
Change in WOMAC physical function score
84 days
SF-36
Time Frame: 84 days
Change in SF-36's various component scores.
84 days
FACIT score
Time Frame: 84 days
Change in FACIT score
84 days
Rescue medication consumption
Time Frame: 84 days
Change in rescue medication consumption.
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vedic Lifesciences Pvt. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shalini Srivastava, MD, Vedic Lifesciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VL/170105/PA/OA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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