Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
Study NCT ID:
NCT06657495
Status:
RECRUITING
Last Update Posted:
2024-10-24
First Post:
2024-09-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety and Efficacy of TD0015 Pilulae in Patients with Knee Osteoarthritis
Sponsor:
Sao Thai Duong Joint Stock Company
Organization:
Study Overview
Official Title:
Thử Nghiệm Lâm Sàng Giai Đoạn 2, Ngẫu Nhiên, Mù Đôi, Có Đối Chứng Giả Dược Để Đánh Giá Tính an Toàn Và Hiệu Quả Của Viên Hoàn Cứng TD0015 Trên Bệnh Nhân Thoái Hóa Khớp Gối
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
The study objective is to evaluate the safety and efficacy of TD0015 pilulae to determine the optimal dose for investigational product. Phase II analyzes is performed on 90 patients and based on the results of phase II to adjust sample size and study design (if applicable) for phase III.
The trial lasts for \~ 30 months with 6 subject visits (from T0 to T5) and is conducted in National Hospital of Traditional Medicine (Hanoi, Vietnam).
Screening procedure occurs at T0 visit, followed by T1 (15+/-3 days), T2 (30+/-3 days), T3 (45+/-3 days), T4 (60+/-3 days) and T5 (90+/-3 days). The telephone contact visits are performed every 2 weeks by Investigators There are 2 levels of dosages: estimated dose - 5g (arm 1) and 1.5 times (arm 2) of estimated dose - 7.5g. There is also another arm using placebo, thus the trial have 3 arms in total.
As for 3 arms, patients is allowed to use oral NSAIDs (meloxicam 7,5mg x 1-2 tablets/day) when pain is severe.
Treatment time is 60 days. IP is used after a meal, 1 pack/time x 2 times/day.
The trial lasts for \~ 30 months with 6 subject visits (from T0 to T5) and is conducted in National Hospital of Traditional Medicine (Hanoi, Vietnam).
Screening procedure occurs at T0 visit, followed by T1 (15+/-3 days), T2 (30+/-3 days), T3 (45+/-3 days), T4 (60+/-3 days) and T5 (90+/-3 days). The telephone contact visits are performed every 2 weeks by Investigators There are 2 levels of dosages: estimated dose - 5g (arm 1) and 1.5 times (arm 2) of estimated dose - 7.5g. There is also another arm using placebo, thus the trial have 3 arms in total.
As for 3 arms, patients is allowed to use oral NSAIDs (meloxicam 7,5mg x 1-2 tablets/day) when pain is severe.
Treatment time is 60 days. IP is used after a meal, 1 pack/time x 2 times/day.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: