Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis

November 3, 2024 updated by: Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled Clinical Study

The clinical trial has a research cycle of 24 weeks. The first 12 weeks are multicenter, randomized, double-blind, controlled trials. A total of 72 patients with knee osteoarthritis with liver-kidney deficiency syndrome and/or cold-dampness arthralgia syndrome are planned to be enrolled and randomly assigned to the control group (Tongren-Dahuoluo Bolus) and the treatment group (Tongren-Dahuoluo Bolus Placebo) in a 1:1 ratio. The purpose is to compare the safety and efficacy of Tongren-Dahuoluo Bolus and placebo in treating knee osteoarthritis. A long-term blind extension study will be conducted in the next 12 weeks. All subjects will take Tongren-Dahuoluo Bolus orally to evaluate the long-term safety, tolerability, and efficacy of Tongren-Dahuoluo Pills in treating patients with knee osteoarthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Estimated)

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.
72

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.
  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, aged 40 to 75 years old;
  2. Meet the diagnostic criteria for primary knee osteoarthritis (KOA) (the diagnostic criteria refer to the 1995 American College of Rheumatology classification criteria for knee osteoarthritis);
  3. Meet the diagnostic criteria for liver and kidney deficiency and (or) cold and dampness obstruction in the group standard of the Chinese Association of Traditional Chinese Medicine "Guidelines for Combination of Osteoarthritis Symptoms";
  4. X-ray examination of the joints is graded as I to III (knee joint Kellgren/Lawrence e scoring standard);
  5. Knee pain score ≥40mm in the past week (assessed by VAS standard);

Exclusion Criteria:

  1. Patients with other rheumatic diseases such as Sjögren's syndrome, gout, rheumatoid arthritis, or a history of human immunodeficiency virus (HIV);
  2. Patients with severe lesions of important organs such as the heart, liver, and kidney, abnormal liver function (alanine or aspartate aminotransferase or glutamine transpeptidase>1.5 times the upper limit of normal value); or abnormal renal function (serum creatinine level> upper limit of normal value); white blood cell (white blood cell, WBC) or platelet (platelet, PLT) below the lower limit of normal value; or diabetic patients with poor blood sugar control in the recent period (glycosylated hemoglobin>8.0%);
  3. Patients with suppurative, nonspecific, and other infectious knee arthritis;
  4. Patients with traumatic, villonodular pigmentation and other lesions with knee synovium as the main lesions;
  5. Patients with advanced joint deformity or disability; A randomized controlled study on Tongren Dahuoluowan in the treatment of knee osteoarthritis Version number: 2023009P8A01 Version date: December 23, 2022
  6. Allergic constitution and allergic to the test drug;
  7. Pregnant, pregnant, or lactating women;
  8. Those who are taking antidepressants, anticonvulsants, opioids, sedatives and glucocorticoids;
  9. Patients who have received intra-articular treatment with sodium hyaluronate within 4 weeks before screening; those who have taken drugs containing chondroitin sulfate/glucosamine/diacerein within 3 months before screening; those who have used biological agents within 3 months before screening;
  10. Patients with organ failure symptoms;
  11. Those who have participated in any other drug trials within 1 month before selection;
  12. Those who the researcher believes are not eligible to join this clinical trial

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: Crossover Assignment
  • Masking: Double

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.
Experimental: Treatment of Tongren Dahuoluo Pills
Drug: Tongren-Dahuoluo Bolus
0.72g,2 times a day, oral, for 24 weeks.
Placebo Comparator: Treatment of Tongren-Dahuoluo Bolus Placebo
Drug: Tongren-Dahuoluo Bolus Placebo
0.72g,2 times a day, oral, for 12 weeks.

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
Changes from Baseline to week 24 in Visual Analog Scale (VAS)score
Time Frame: 0 week, 4 weeks,12 weeks, 24 weeks
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
0 week, 4 weeks,12 weeks, 24 weeks

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
Changes in the 30s-CST frequency (30-second chair sit-stand test) of the experimental group relative to the baseline and control group at the 4th, 12th, and 24th weeks;
Time Frame: 0 week, 4 weeks,12 weeks, 24 weeks
0 week, 4 weeks,12 weeks, 24 weeks
Changes in knee osteoarthritis index (WOMAC score) at week 4, week 12, and week 24 relative to baseline and control group
Time Frame: 0 week, 4 weeks,12 weeks, 24 weeks
0 week, 4 weeks,12 weeks, 24 weeks
Changes in TCM syndrome score evaluation at week 4, week 12, and week 24 relative to baseline and control group;
Time Frame: 0 week, 4 weeks,12 weeks, 24 weeks
0 week, 4 weeks,12 weeks, 24 weeks
Changes in KOOS scores of knee injury and osteoarthritis outcomes at weeks 4, 12, and 24 relative to baseline and the control group
Time Frame: 0 week, 4 weeks,12 weeks, 24 weeks
0 week, 4 weeks,12 weeks, 24 weeks
Changes in SF-12 at week 4, week 12, and week 24 relative to baseline and control group
Time Frame: 0 week, 4 weeks,12 weeks, 24 weeks
0 week, 4 weeks,12 weeks, 24 weeks
Changes in serum inflammatory indicators (CRP) relative to baseline and control group at week 4, week 12, and week 24
Time Frame: 0 week, 4 weeks,12 weeks, 24 weeks
CRP in μg/L
0 week, 4 weeks,12 weeks, 24 weeks
Changes in serum inflammatory indicators (ESR) relative to baseline and control group at week 4, week 12, and week 24
Time Frame: 0 weeks, 4 weeks,12 weeks, 24 weeks
ESR in mm/h
0 weeks, 4 weeks,12 weeks, 24 weeks
MRI examination of the knee joint (target joint) at the time of enrollment and at week 24 to examine the changes in bone marrow edema, joint effusion, synovitis, cartilage volume and composition relative to the baseline and control group
Time Frame: 0 week, 4 weeks,12 weeks, 24 weeks
0 week, 4 weeks,12 weeks, 24 weeks

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.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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 (Estimated)

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.
January 10, 2025

Primary Completion (Estimated)

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.
June 30, 2025

Study Completion (Estimated)

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.
December 30, 2025

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).
October 30, 2024

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.
November 3, 2024

First Posted (Estimated)

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.
November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
November 5, 2024

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.
November 3, 2024

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.
November 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 2023-170-YW-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethical Considerations: Adhering to ethical guidelines that prioritize patient consent and data protection.

Lack of Consent: Patients may not have consented to share their data publicly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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