AzTrials
AzTrials

Knee OsteoarthritisPhase 2NCT06657495

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

A Phase 2 study testing TD0015 in people with Knee Osteoarthritis, run by Sao Thai Duong Joint Stock Company at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthritis
What is being tested?
TD0015
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteVietnam
Study dates
1 Jul 2021to Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥ 18 years old must meet ALL or the following criteria clusters 1,2,6 or 1,3,5,6 or 1,4,5,6 to be enrolled:
  • Knee pain
  • Bone spurs forming along the edges of the joint, narrowing of joint space in X-ray film (grade I-III) according to Kellgren and Lawrence
  • Knee joint effusion
  • Morning stiffness that lasts less than 30 minutes when moving
  • Knee crepitus when moving
  • Patient voluntarily agree and and sign in the ICF
  • According to traditional medicine: The disease type is Wind-Cold-Damp Bi with Kidney and Liver Deficiency. Symptoms are knee joint is pain, cold and heavy. Pain is usually fixed, little movement, mild during the day, severe at night, increased in cold and wet weather. Warm compresses to relieve pain, knee joint may be swollen, limited movement, may have morning stiffness, joint deformity associated with muscle atrophy, back pain, not warm limbs.The tongue is pale, the tongue is white and greasy, and deep-thready-weak pulse.

Who cannot join

  • Hypersensitivity to any subtances of TD0015 pilulae.
  • Pregnant or lactating
  • Currently having surgical indications.
  • Other conditions asseted by the investigator that are not eligible to be enrolled.
  • Knee Osteoarthritis grade IV according to classification of Kellgren and Lawrence (specify that large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends)
  • Self-administration of other anti-inflammatory medicine (except for NSAIDs) during study period as for 3 arms
Show all 15Show fewer
  • Patient is treated by NSAIDs within 3 days or has corticosteroid Intra-articular injection within 3 months prior to enrolment
  • Joint and/or systemic infections
  • Cardiovascular diseases (arrhythmia, hypertension) without treatment
  • Cross - hypertensitivity to aspirin or other NSAIDs
  • History of recent or progressive peptic ulcer/gastrointestinal perforation
  • Severe liver failure
  • Severe renal failure without dialysis
  • Gastrointestinal hemorrhage, recent brain hemorrhage or disorders causing systemic hemorrhage
  • Uncontrolled heart failure

Trial locations and contacts

1 site in 1 country.

Hong Van Thi Nguyen, MSC contact

(+84)916451269

vannh@thaiduong.com.vn

Vietnam1 site, 1 recruiting

  • National Hospital of Traditional Medicine

    Hanoi, 100000

    Ha Thi Thu Nguyen, M.D., PhD., Level 2 Specialist, hachi005@yahoo.com

    Ha Thi Thu Nguyen, M.D., PhD., Level 2 Specialist

    Recruiting

Other trials in Vietnam

About this study

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

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.

Read the 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.

Being tested
TD0015, TD0015 Placebo
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TD0015Drug

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

  • TD0015 PlaceboDrug

    Placebo was packed in pack 5g

Study groups in NCT06657495
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo pilulae weighing 5g/pack, after a meal, 1pack/time x 2 times/day
Receives: Drug: TD0015 Placebo
Investigational product 1Experimentalestimated dose:TD0015 pilulae weighing 5g/pack , after a meal, 1pack/time x 2 times/day
Receives: Drug: TD0015
Investigational product 2Experimental1.5 times of estimated dose: TD0015 pilulae weighing 7.5g/pack , after a meal, 1pack/time x 2 times/day
Receives: Drug: TD0015

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline on the Western Ontario and McMaster Universities Osteoarthrities Index) WOMAC to evaluate the level of symptoms

    WOMAC was scored by investigator in visits (T1, T2, T3, T4, T5) and compared with T0

    Measured: Day 15th, day 30th, day 45th, day 60th and day 30th after end of study

  2. Change from baseline in Pain Scores on the Visual Analog Scale

    VAS scale: 0 = no pain | 0-->2: mild | 2-->4: moderate | 4--> 6: severe | 6->8: extreme | 8-->10: untolerable

    Evaluate outcome of treatment according to VAS scale:

    • Very Good: 0
    • Good: 1 - 4
    • Average: 5 - 7
    • Weak: >8

    Measured: day 15th, day 30th, day 45th, day 60th and day 30th after end of study

  3. Change in symptoms severity was reported by patient on the Lequesne Index

    Lequesne Index at prior and after treatment (day 15th, day 30th, day 45th, day 60th and day 30th after end of study).

    Measured: day 15th, day 30th, day 45th, day 60th and day 30th after end of study

  4. Percentage of patients taking rescue medication

    3 Arms were allowed to use oral NSAIDs (meloxicam 7,5 mg x 1-2 tablets/day) when pain was severe. All NSAIDs in the study need to be documented in detail

    Measured: 90 days

  5. The average dose of rescue medication was used

    Measured: 90 days

  6. Frequency of AE, SAE

    Reference CTCAE 4.03

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start1 Jul 2021
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three arms: basic dose, 1.5 basic dose and placebo
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06657495
Sponsor's protocol ID
TD0015
Status last verified
Feb 2024
First submitted
22 Sep 2024
Last updated
24 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ha NTT, Nghia DT, Nga HTV, Lua TT, Hong NTB, Hanh NT, Ngoc NK, Vuong NL. Traditional Vietnamese herbal medicine TD0015 in Knee Osteoarthritis: A Phase-II randomized controlled trial. Integr Med Res. 2025 Jun;14(2):101143. doi: 10.1016/j.imr.2025.101143. Epub 2025 Mar 31.

    PubMed 40290409

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TD0015 in people with Knee Osteoarthritis, run by Sao Thai Duong Joint Stock Company at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hong Van Thi Nguyen, MSC ((+84)916451269, vannh@thaiduong.com.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline on the Western Ontario and McMaster Universities Osteoarthrities Index) WOMAC to evaluate the level of symptoms (time frame: Day 15th, day 30th, day 45th, day 60th and day 30th after end of study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06657495, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in