Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657495
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
To Evaluate the Safety and Efficacy of TD0015 Pilulae in Patients with Knee Osteoarthritis
Sponsor:
None
Organization:
None
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:
No
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 concernsThe 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 15 times arm 2 of estimated dose - 75g 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 75mg x 1-2 tabletsday when pain is severe
Treatment time is 60 days IP is used after a meal 1 packtime x 2 timesday
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 15 times arm 2 of estimated dose - 75g 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 75mg x 1-2 tabletsday when pain is severe
Treatment time is 60 days IP is used after a meal 1 packtime x 2 timesday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None