Peripheral Arterial DiseasePhase 2NCT02380794
Novel Treatment of Intermittent Claudication in Patients With Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule
A Phase 2 study testing Danshen Gegen Capsule in people with Peripheral Arterial Disease and Intermittent Claudication, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant proportion of the population with an age-adjusted prevalence of approximately 12%. Claudication induced walking impairment can be debilitating and adversely affects social, leisure, and occupational activities in many patients… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- Danshen Gegen Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Oct 2015to 2 Jun 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 40 years or older
- With stable intermittent claudication secondary to PAD defined as resting ABI <0.90 and a ≥10mmHg decrease in ankle artery blood pressure after exercise.
- No change in existing therapy for claudication within 3 months of study enrollment.
Who cannot join
- Critical limb ischemia defined by ischemic rest pain, ulceration, or gangrene
- Major lower limb amputation
- Surgical or endovascular revascularization for PAD within 3 months prior to enrolment
- Exercise limitation due to significant concomitant disease (e.g. severe arthritis, cardiac or pulmonary disease)
- Pregnant women and women who are breastfeeding
- Patients who are currently on Warfarin
- Patients with resting systolic blood pressure below 100mmHg (SBP < 100mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant proportion of the population with an age-adjusted prevalence of approximately 12%. Claudication induced walking impairment can be debilitating and adversely affects social, leisure, and occupational activities in many patients and is associated with higher mortality among PAD patients.
Unfortunately, very few effective therapies are available to improve leg symptoms and exercise performance in PAD patients. Surgery is the last resort but results vary. Therefore, there is a large unmet need for medical therapies that can improve long-term walking performance and functional capacity in PAD patients.
Read more
Danshen and Gegen (D\&G) are commonly used Chinese herbal medicine in the treatment of cardiovascular diseases. D\&G study has been extensively researched and continued at The Chinese University of Hong Kong (CUHK) for their antioxidative and vasodilator properties, modulate anti-atherosclerosis and improve arthrogenic athophysiology. Three randomized trials were completed at the CUHK showing D\&G improved lipid profile, vascular function and thinned down the internal layer of the carotid artery. One may expect the same with lower limb arteries. Extensive clinical experiences of use in China and Hong Kong indicated that D\&G are well tolerated and safe.
This project is a randomized control trial to determine the efficacy and Safety of D\&G in improving the functional capacity \& QoL in patients with symptomatic PAD. The results of this study have the potential to change local and international practice in providing a much needed therapeutic option in the treatment of PAD.
Read the detailed description
Peripheral arterial disease involving the lower limbs is becoming an increasingly important health issue which places considerable burden on individuals, communities and health care resources. PAD affects an estimated 27 million adults >55 years of age in Europe and North America (1). The prevalence of PAD in Asia is expected to be similar and is likely to rise as the Chinese population ages. Intermittent claudication affects most patients with PAD. Although IC is not limb-threatening, the loss of walking ability and the experience of pain with ambulation can cause significant social, leisure, and occupational impairment in many patients (2-4). The decreased QoL experienced in patients with IC is on par with other cardiovascular diseases such as heart failure and heart attack. More alarmingly, physical disability is associated with higher risk of death among PAD patients. For these reasons and because patients are chronically disabled, the treatment of IC has increasingly become a major clinical focus in cardiovascular research.
For PAD patients, it is critical to focus on therapies that can reduce the underlying cardiovascular risk as well as improving functional status and Qol. Although multiple therapies (antiplatelet agents, statins, anti-hypertensive agents) have been proven to reduce cardiovascular risk in PAD patients, very few therapeutic agents have been shown to improve symptoms of IC in PAD patients (5). As such there is a large unmet need in terms of leg-specific therapies that can improve walking performance and functional capacity for this debilitating disease. Traditional Chinese herbal medicine such as Danshen and Gegen are well established in the treatment of cardiovascular diseases and well tolerated by most patients. The studies done at the Institute of Chinese Medicine of the CUHK showed particularly encouraging results (6-8). The outcomes of this study have the potential to change local and international practice in providing a novel therapeutic option in the treatment of symptomatic PAD. As parallel laboratory research is being done to identify the most active components of the D\&G formula in preparation for drug development, the efficacy of D\&G in PAD will offer more assurance for the systemic efforts.
- Being tested
- Danshen Gegen Capsule, Placebo
- Keywords
- Danshen Gegen Capsule
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danshen Gegen CapsuleDrug
Also called D&G
Danshen can dilate blood vessels, reduce the number of angina attacks and significantly improve endothelial function in patients with Coronary Angina Pectoris.
Gegen is also effective in dilating cardiovascular and cerebrovascular of the brain, and improving blood circulation. The main active ingredient of Gegen isoflavones is effective in dilating the coronary arteries, improving metabolism in normal and ischemic myocardium and reducing blood pressure, heart rate and myocardial oxygen consumption.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Danshen Gegen Capsule | Active comparator | 3 capsules (500 mg per capsule) twice daily for 24 weeks Receives: Drug: Danshen Gegen Capsule |
| Placebo | Placebo comparator | 3 capsules (500 mg per capsule) twice daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total distance walked on a standardized graded treadmill
Measured: between baseline and 24 weeks
Secondary outcomes (6)
Change in distance walked to onset of claudication
Measured: between baseline and 24 weeks
Change in health related quality of life assessed by EuroQol-5 Dimension
Measured: between baseline and 24 weeks
Change in functional status assessed by Walking Impairment Questionnaire
Measured: between baseline and 24 weeks
Rates of combined cardiovascular events including vascular death, myocardial infarction, stroke, revascularization, or readmission to hospital for a vascular or atherosclerosis-related complication
Measured: At 24 weeks
Change in ankle brachial index before and after exercise by brachial-to-ankle pulse wave velocity
Measured: between baseline and 24 weeks
Changes in arterial stiffness assessed by brachial-to-ankle pulse wave velocity
Measured: between baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study start28 Oct 2015
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
- Investigators
- Bryan Ping Yen YAN, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380794
- Sponsor's protocol ID
- DG-PAD
- Status last verified
- Jul 2019
- First submitted
- 10 Feb 2015
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Criqui MH, Fronek A, Barrett-Connor E, Klauber MR, Gabriel S, Goodman D. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985 Mar;71(3):510-5. doi: 10.1161/01.cir.71.3.510.
PubMed 3156006Kannel WB, McGee DL. Update on some epidemiologic features of intermittent claudication: the Framingham Study. J Am Geriatr Soc. 1985 Jan;33(1):13-8. doi: 10.1111/j.1532-5415.1985.tb02853.x.
PubMed 3965550McDermott MM, Greenland P, Liu K, Guralnik JM, Celic L, Criqui MH, Chan C, Martin GJ, Schneider J, Pearce WH, Taylor LM, Clark E. The ankle brachial index is associated with leg function and physical activity: the Walking and Leg Circulation Study. Ann Intern Med. 2002 Jun 18;136(12):873-83. doi: 10.7326/0003-4819-136-12-200206180-00008.
PubMed 12069561McDermott MM, Liu K, Greenland P, Guralnik JM, Criqui MH, Chan C, Pearce WH, Schneider JR, Ferrucci L, Celic L, Taylor LM, Vonesh E, Martin GJ, Clark E. Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. JAMA. 2004 Jul 28;292(4):453-61. doi: 10.1001/jama.292.4.453.
PubMed 15280343Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
PubMed 16549646Chan YL, Woo KS, Leung PC, Fung KP. Traditional Chinese medicine Danshen-Gegen combination formula improves atherogenic pathophysiology: an in-vitro and ex-vivo study. Journal of the Hong Kong College of Cardiology. 2006;14:28.
Tam LWY, Chook, P, Poon PYK, Qiao M, Chan LLT, Cheung ASP, Chan TYK,Fung KP, Tang KSL, Lau VKM, Koon JCM, Leung PC, Celemajer DS, Woo KS. Danshen and Gegen as cardiovascular tonic in coronary patients: a novel strategy for secondary atherosclerosis prevention. Journal of the Hong Kong College of Cardiology. 2004;12:32.
McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001 Oct 3;286(13):1599-606. doi: 10.1001/jama.286.13.1599.
PubMed 11585483
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment of Intermittent Claudication in Patients With Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule
- ClinicalTrials.gov ID
- NCT02380794
- Acronym / sponsor ID
- DG-PAD
- Keywords
- Danshen Gegen Capsule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant proportion of the population with an age-adjusted prevalence of approximately 12%. Claudication induced walking impairment can be debilitating and adversely affects social, leisure, and occupational activities in many patients and is associated with higher mortality among PAD patients.
Unfortunately, very few effective therapies are available to improve leg symptoms and exercise performance in PAD patients. Surgery is the last resort but results vary. Therefore, there is a large unmet need for medical therapies that can improve long-term walking performance and functional capacity in PAD patients.
Danshen and Gegen (D\&G) are commonly used Chinese herbal medicine in the treatment of cardiovascular diseases. D\&G study has been extensively researched and continued at The Chinese University of Hong Kong (CUHK) for their antioxidative and vasodilator properties, modulate anti-atherosclerosis and improve arthrogenic athophysiology. Three randomized trials were completed at the CUHK showing D\&G improved lipid profile, vascular function and thinned down the internal layer of the carotid artery. One may expect the same with lower limb arteries. Extensive clinical experiences of use in China and Hong Kong indicated that D\&G are well tolerated and safe.
This project is a randomized control trial to determine the efficacy and Safety of D\&G in improving the functional capacity \& QoL in patients with symptomatic PAD. The results of this study have the potential to change local and international practice in providing a much needed therapeutic option in the treatment of PAD.
Detailed description
Peripheral arterial disease involving the lower limbs is becoming an increasingly important health issue which places considerable burden on individuals, communities and health care resources. PAD affects an estimated 27 million adults >55 years of age in Europe and North America (1). The prevalence of PAD in Asia is expected to be similar and is likely to rise as the Chinese population ages. Intermittent claudication affects most patients with PAD. Although IC is not limb-threatening, the loss of walking ability and the experience of pain with ambulation can cause significant social, leisure, and occupational impairment in many patients (2-4). The decreased QoL experienced in patients with IC is on par with other cardiovascular diseases such as heart failure and heart attack. More alarmingly, physical disability is associated with higher risk of death among PAD patients. For these reasons and because patients are chronically disabled, the treatment of IC has increasingly become a major clinical focus in cardiovascular research.
For PAD patients, it is critical to focus on therapies that can reduce the underlying cardiovascular risk as well as improving functional status and Qol. Although multiple therapies (antiplatelet agents, statins, anti-hypertensive agents) have been proven to reduce cardiovascular risk in PAD patients, very few therapeutic agents have been shown to improve symptoms of IC in PAD patients (5). As such there is a large unmet need in terms of leg-specific therapies that can improve walking performance and functional capacity for this debilitating disease. Traditional Chinese herbal medicine such as Danshen and Gegen are well established in the treatment of cardiovascular diseases and well tolerated by most patients. The studies done at the Institute of Chinese Medicine of the CUHK showed particularly encouraging results (6-8). The outcomes of this study have the potential to change local and international practice in providing a novel therapeutic option in the treatment of symptomatic PAD. As parallel laboratory research is being done to identify the most active components of the D\&G formula in preparation for drug development, the efficacy of D\&G in PAD will offer more assurance for the systemic efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Danshen Gegen Capsule | Active comparator | Drug: Danshen Gegen Capsule3 capsules (500 mg per capsule) twice daily for 24 weeks |
| Placebo | Placebo comparator | Drug: Placebo3 capsules (500 mg per capsule) twice daily for 24 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 40 years or older
- With stable intermittent claudication secondary to PAD defined as resting ABI <0.90 and a ≥10mmHg decrease in ankle artery blood pressure after exercise.
- No change in existing therapy for claudication within 3 months of study enrollment.
Key exclusion criteria (7 listed)
- Critical limb ischemia defined by ischemic rest pain, ulceration, or gangrene
- Major lower limb amputation
- Surgical or endovascular revascularization for PAD within 3 months prior to enrolment
- Exercise limitation due to significant concomitant disease (e.g. severe arthritis, cardiac or pulmonary disease)
- Pregnant women and women who are breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Danshen Gegen CapsuleAlso: D&GDanshen can dilate blood vessels, reduce the number of angina attacks and significantly improve endothelial function in patients with Coronary Angina Pectoris. Gegen is also effective in dilating cardiovascular and cerebrovascular of the brain, and improving blood circulation. The main active ingredient of Gegen isoflavones is effective in dilating the coronary arteries, improving metabolism in normal and ischemic myocardium and reducing blood pressure, heart rate and myocardial oxygen consumption. | Drug | Danshen Gegen Capsule |
| Placebo | Drug | Placebo |
Primary outcome
Change in total distance walked on a standardized graded treadmill
Time frame: between baseline and 24 weeks
6 secondary outcomes
Change in distance walked to onset of claudication
Time frame: between baseline and 24 weeks
Change in health related quality of life assessed by EuroQol-5 Dimension
Time frame: between baseline and 24 weeks
Change in functional status assessed by Walking Impairment Questionnaire
Time frame: between baseline and 24 weeks
Rates of combined cardiovascular events including vascular death, myocardial infarction, stroke, revascularization, or readmission to hospital for a vascular or atherosclerosis-related complication
Time frame: At 24 weeks
Change in ankle brachial index before and after exercise by brachial-to-ankle pulse wave velocity
Time frame: between baseline and 24 weeks
Changes in arterial stiffness assessed by brachial-to-ankle pulse wave velocity
Time frame: between baseline and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Background: PubMed 3156006Criqui MH, Fronek A, Barrett-Connor E, Klauber MR, Gabriel S, Goodman D. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985 Mar;71(3):510-5. doi: 10.1161/01.cir.71.3.510.
- Background: PubMed 3965550Kannel WB, McGee DL. Update on some epidemiologic features of intermittent claudication: the Framingham Study. J Am Geriatr Soc. 1985 Jan;33(1):13-8. doi: 10.1111/j.1532-5415.1985.tb02853.x.
- Background: PubMed 12069561McDermott MM, Greenland P, Liu K, Guralnik JM, Celic L, Criqui MH, Chan C, Martin GJ, Schneider J, Pearce WH, Taylor LM, Clark E. The ankle brachial index is associated with leg function and physical activity: the Walking and Leg Circulation Study. Ann Intern Med. 2002 Jun 18;136(12):873-83. doi: 10.7326/0003-4819-136-12-200206180-00008.
- Background: PubMed 15280343McDermott MM, Liu K, Greenland P, Guralnik JM, Criqui MH, Chan C, Pearce WH, Schneider JR, Ferrucci L, Celic L, Taylor LM, Vonesh E, Martin GJ, Clark E. Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. JAMA. 2004 Jul 28;292(4):453-61. doi: 10.1001/jama.292.4.453.
- Background: PubMed 16549646Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
- BackgroundChan YL, Woo KS, Leung PC, Fung KP. Traditional Chinese medicine Danshen-Gegen combination formula improves atherogenic pathophysiology: an in-vitro and ex-vivo study. Journal of the Hong Kong College of Cardiology. 2006;14:28.
- BackgroundTam LWY, Chook, P, Poon PYK, Qiao M, Chan LLT, Cheung ASP, Chan TYK,Fung KP, Tang KSL, Lau VKM, Koon JCM, Leung PC, Celemajer DS, Woo KS. Danshen and Gegen as cardiovascular tonic in coronary patients: a novel strategy for secondary atherosclerosis prevention. Journal of the Hong Kong College of Cardiology. 2004;12:32.
- Background: PubMed 11585483McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001 Oct 3;286(13):1599-606. doi: 10.1001/jama.286.13.1599.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Ping Yen YAN principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Danshen Gegen Capsule in people with Peripheral Arterial Disease and Intermittent Claudication, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jul 2019. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total distance walked on a standardized graded treadmill (time frame: between baseline and 24 weeks). 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 NCT02380794, which also lists 8 linked publications.
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 29 Jul 2019.