Traditional Vietnamese herbal medicine TD0015 in Knee Osteoarthritis: A Phase-II randomized controlled trial

IF 2.8 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research Pub Date : 2025-03-31 DOI:10.1016/j.imr.2025.101143

Nguyen Thi Thu Ha , Duong Trong Nghia , Ha Thi Viet Nga , Trinh Thi Lua , Nguyen Thi Bich Hong , Nguyen Thi Hanh , Nguyen Kim Ngoc , Nguyen Lam Vuong

{"title":"Traditional Vietnamese herbal medicine TD0015 in Knee Osteoarthritis: A Phase-II randomized controlled trial","authors":"Nguyen Thi Thu Ha , Duong Trong Nghia , Ha Thi Viet Nga , Trinh Thi Lua , Nguyen Thi Bich Hong , Nguyen Thi Hanh , Nguyen Kim Ngoc , Nguyen Lam Vuong","doi":"10.1016/j.imr.2025.101143","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Knee osteoarthritis (KOA) is a leading cause of disability among older adults worldwide. Traditional medicine offers a promising treatment for KOA with fewer side effects compared to current treatments such as non-steroidal anti-inflammatory drugs and corticosteroids. This study aimed to evaluate the safety and efficacy of TD0015, a herbal formulation based on the Duhuo Jisheng decoction, in treating KOA.</div></div><div><h3>Methods</h3><div>This randomized, double-blind, placebo-controlled trial enrolled 108 patients with KOA. Participants were randomly assigned in a 1:1:1 ratio to receive TD0015 5 g, TD0015 7.5 g, or placebo daily for 60 days. Efficacy endpoints included changes in Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), Visual Analogue Scale (VAS), Lequesne index, heel-buttock distance, and knee flexion and extension range of motion. Safety was assessed by adverse events (AEs).</div></div><div><h3>Results</h3><div>The mean age was around 60 years, and >80 % were females. Both TD0015 treatment groups significantly improved the WOMAC, VAS, Lequesne score, heel-buttock distance, and knee flexion and extension during the treatment period. At the 90-day follow-up, the mean percentage improvement in WOMAC scores was 74.5 % ± 13.4 %, 83.9 % ± 14.8 %, and 7.4 % ± 31.5 % in the TD0015 5 g, TD0015 7.5 g, and placebo groups, respectively, which corresponds to a 67.1 % (95 % CI: 56.3–77.9) and 76.5 % (95 % CI: 65.6–87.4) improvement in the TD0015 5 g and TD0015 7.5 g groups, compared to placebo. No AEs were reported in any group.</div></div><div><h3>Conclusions</h3><div>The Vietnamese herbal medicine TD0015 is safe, efficacious, and well-tolerated in treating KOA. Further studies are required to confirm the long-term efficacy and safety of TD0015.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov, NCT06657495.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101143"},"PeriodicalIF":2.8000,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Integrative Medicine Research","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S221342202500023X","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Knee osteoarthritis (KOA) is a leading cause of disability among older adults worldwide. Traditional medicine offers a promising treatment for KOA with fewer side effects compared to current treatments such as non-steroidal anti-inflammatory drugs and corticosteroids. This study aimed to evaluate the safety and efficacy of TD0015, a herbal formulation based on the Duhuo Jisheng decoction, in treating KOA.

Methods

This randomized, double-blind, placebo-controlled trial enrolled 108 patients with KOA. Participants were randomly assigned in a 1:1:1 ratio to receive TD0015 5 g, TD0015 7.5 g, or placebo daily for 60 days. Efficacy endpoints included changes in Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), Visual Analogue Scale (VAS), Lequesne index, heel-buttock distance, and knee flexion and extension range of motion. Safety was assessed by adverse events (AEs).

Results

The mean age was around 60 years, and >80 % were females. Both TD0015 treatment groups significantly improved the WOMAC, VAS, Lequesne score, heel-buttock distance, and knee flexion and extension during the treatment period. At the 90-day follow-up, the mean percentage improvement in WOMAC scores was 74.5 % ± 13.4 %, 83.9 % ± 14.8 %, and 7.4 % ± 31.5 % in the TD0015 5 g, TD0015 7.5 g, and placebo groups, respectively, which corresponds to a 67.1 % (95 % CI: 56.3–77.9) and 76.5 % (95 % CI: 65.6–87.4) improvement in the TD0015 5 g and TD0015 7.5 g groups, compared to placebo. No AEs were reported in any group.

Conclusions

The Vietnamese herbal medicine TD0015 is safe, efficacious, and well-tolerated in treating KOA. Further studies are required to confirm the long-term efficacy and safety of TD0015.

Trial registration

ClinicalTrials.gov, NCT06657495.

查看原文本刊更多论文

越南传统草药TD0015治疗膝骨关节炎：一项ii期随机对照试验

膝关节骨关节炎（KOA）是全球老年人致残的主要原因。传统医学为KOA提供了一种有希望的治疗方法，与目前的治疗方法（如非甾体抗炎药和皮质类固醇）相比，它的副作用更少。本研究旨在评价以独活鸡血汤为基础研制的中药制剂TD0015治疗KOA的安全性和有效性。方法本随机、双盲、安慰剂对照试验纳入108例KOA患者。参与者以1:1:1的比例随机分配，每天接受TD0015 5 g， TD0015 7.5 g或安慰剂，持续60天。疗效终点包括西安大略和麦克马斯特大学骨关节炎指数（WOMAC）、视觉模拟量表（VAS）、Lequesne指数、脚跟-臀部距离以及膝关节屈伸活动范围的变化。通过不良事件（ae）评估安全性。结果患者平均年龄60岁左右，女性占80%。TD0015治疗组治疗期间WOMAC、VAS、Lequesne评分、跟臀距离、膝关节屈伸均有显著改善。在90天的随访中，TD0015 5 g组、TD0015 7.5 g组和安慰剂组的WOMAC评分的平均改善百分比分别为74.5%±13.4%、83.9%±14.8%和7.4%±31.5%，与安慰剂组相比，TD0015 5 g组和TD0015 7.5 g组的改善百分比分别为67.1% （95% CI: 56.3-77.9）和76.5% （95% CI: 65.6-87.4）。各组无不良反应发生。结论越南中草药TD0015治疗KOA安全、有效、耐受性好。需要进一步的研究来证实TD0015的长期有效性和安全性。临床试验注册：clinicaltrials .gov, NCT06657495。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Integrative Medicine Research Medicine-Complementary and Alternative Medicine

CiteScore

6.50

自引率

2.90%

发文量

审稿时长

12 weeks

期刊介绍： Integrative Medicine Research (IMR) is a quarterly, peer-reviewed journal focused on scientific research for integrative medicine including traditional medicine (emphasis on acupuncture and herbal medicine), complementary and alternative medicine, and systems medicine. The journal includes papers on basic research, clinical research, methodology, theory, computational analysis and modelling, topical reviews, medical history, education and policy based on physiology, pathology, diagnosis and the systems approach in the field of integrative medicine.