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To Evaluate the Safety and Efficacy of TD0015 Pilulae in Patients with Knee Osteoarthritis

NCT06657495 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-10-24

No results posted yet for this study

Summary

Preclinical trials in animal models have suggested that the estimated dose of TD0015 in clinical presents no safety concerns.The investigational product is TD0015 pilulae, which is based on the traditional prescription named "Độc hoạt tang ký sinh thang" (Thien Kim Phuong).

The traditional prescription has the effect of circulating blood in the tendons and bones to bring out evil spirits, blood tonic, kidney tonic to prevent recurrence of diseases and against joint degeneration, joint deformation, muscle atrophy, stiffness to recover normal joint function.

Conditions

Interventions

DRUG

TD0015

TD0015 is black, dark brown inside pilulae and has special smell of herbal, slightly sour then bitter taste.

DRUG

TD0015 Placebo

Placebo was packed in pack 5g

Sponsors & Collaborators

  • Big Leap Research

    collaborator OTHER

  • Sao Thai Duong Joint Stock Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657495 on ClinicalTrials.gov