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Hemorrhagic StrokePhase 4NCT04200781

Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

A Phase 4 study testing Granules of Shengdi Dahuang Decoction in people with Hemorrhagic Stroke, run by ShuGuang Hospital at 5 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to assess the efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke by the randomized, controlled, double-blind, multi-center trial design project. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Hemorrhagic Stroke
What is being tested?
Granules of Shengdi Dahuang Decoction
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
464 participants
Where
5 sitesChina
Study dates
1 Sep 2019to 30 Jun 2022
Phase
Phase 4
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet the diagnostic criteria of acute intracerebral hemorrhage；
  • CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is <80ml;
  • The time from onset to confirmed diagnosis by CT scan is within 4 hours;
  • Enrolled and receive treatment within 12 hours from onset;
  • Age ≥18 years old;
  • Obtain approval from the patient or family members.

Who cannot join

  • The time from onset to confirmed diagnosis by CT scan is over 4 hours;
  • CT scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one);
  • The volume of hematoma is above 80ml;
  • Glasgow Coma Scale (GCS) is ≤ 5 points;
  • The time from onset to confirmed diagnosis is over 12 hours;
  • Have a surgical treatment planning within 24 hours;
Show all 12Show fewer
  • Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons;
  • Patients with disabilities before onset (modified mRS score > 2);
  • Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system;
  • Patients who have participated in other clinical trials within the past 1 month;
  • Pregnant or nursing women;
  • Allergic constitution (allergic to more than two kinds of food or medications).

Trial locations and contacts

5 sites in 1 country.

Xiaoyu Yu contact

86-021-20256378

doctorxiaoyu@sina.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM

    Shanghai, Shanghai Municipality, 200000

    Feng Wang, +86-13816566556, 13816566556@163.com

    Recruiting

  • Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200000

    Jingyan Xiang, 86-18930173850, xiang_jing_yan@aliyun.com

    Recruiting

  • Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200000

    Xiaoyu Zhou, 86-18049929570, 13564532819@163.com

    Recruiting

  • Shuguang Hospital affiliated with Shanghai University of TCM

    Shanghai, Shanghai Municipality, 200000

    Xiaofei Yu, 86-13331978806, doctorxiaoyu@sina.com

    Recruiting

  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200000

    Yan Han, 86-13917022800, hanyan.2006@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Controlled, Double-blind, Multi-center Clinical Study of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

The purpose of this study is to assess the efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke by the randomized, controlled, double-blind, multi-center trial design project.

Read the detailed description

The main purpose of the study is to observe the clinical efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke. This project is funded by Science and Technology Commission of Shanghai Municipality and will be carried out in 5 hospitals. Investigators will recruit 464 participants who meet the inclusion criteria and agree to participate in the research. Participants will be randomly assigned into experimental or placebo group. Granules of Shengdi Decoction is the therapeutic drug used in the experimental group. Each pack of the test drug contains 15 grams of rehmannia and 5 grams of rhubarb. While for the placebo group, each pack contains 2% rehmannia and rhubarb. Participants will receive a follow-up observation in the following 90 days. Modified Rankin Scale score (mRS), the mortality rate on day 7 and day 90 after treatment, National Institute of Health Stroke Scale (NIHSS), expansion rate of hematoma, the degree of edema and the expressions of inflammatory indicators will be detected to evaluate the clinical efficacy of Shengdi Dahuang Decoction.

Being tested
Granules of Shengdi Dahuang Decoction, Placebo
Keywords
acute hemorrhagic stroke, Shengdi Dahuang Decoction
Medical subject headings
Hemorrhagic Stroke

What participants receive

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

  • Granules of Shengdi Dahuang DecoctionDrug

    Also called Chinese Herbal Compound

    Shengdi Dahuang Decoction contains Shengdi (rehmannia) and Dahuang ( rhubarb). Each pack of the granules of Shengdi Dahuang Decoction contains 15 grams of rehmannia and 5 grams of rhubarb.

  • PlaceboDrug

    Also called Placebo of Chinese Herbal Compound

    Placebo granules has the same appearence, weight, shape and color as the experimental drug.

Study groups in NCT04200781
Study groupRoleWhat they receive
Shengdi Dahuang DecoctionExperimentalTo clarify the clinical effects of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke and to explore the possible mechanism. Participants will take the granules of Shengdi Dahuang Decoction that contains 15 grams of rehmannia and 5 grams of rhubarb, one pack per time, twice a day for 7 days.
Receives: Drug: Granules of Shengdi Dahuang Decoction
PlaceboPlacebo comparatorTo explore the effective clinical therapy in acute hemorrhagic stroke. Participants will take placebo contains 2% rehmannia and rhubarb, one pack per time, twice a day for 7 days.
Receives: Drug: Placebo

What is being measured

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

  1. Disability rate

    Modified Rankin Scale score (mRS) will be graded on the 90th day after onset (mRS score ranges from 0 point (no symptoms at all) to 5 points (severe disability)).

    Measured: 90 days

  2. Mortality rate on the 7th day

    The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.

    Measured: 7 days

Secondary outcomes (4)

  1. Mortality rate on the 90th day

    The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.

    Measured: 90 days

  2. Severity of neurological deficit

    National Institute of Health Stroke Scale (NIHSS) will be used to assess the severity of neurological deficit on the 7th day after treatment. NIHSS score ranges from 0 point to 42 points. More severe neurological deficit could be observed in participants with the higher score.

    Measured: 7 days

  3. The proportion of hematoma enlargement cases

    All participants will reexamine the skull CT scan 24 hours after onset. The volume of hematoma (ml) increases more than 6ml or 33% relative increment than original volume is defined as the expansion of hematoma. The proportion of hematoma enlargement cases (%) will be compared between different groups.

    Measured: 24 hours

  4. Severity of edema

    All participants will reexamine the skull CT scan on the 7th day after treatment. The volume (ml) of edema and hematoma will be calculated respectively. The ratio of edema volume and hematoma volume represents the severity of edema.

    Measured: 7 days

Timeline

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

  1. First posted16 Dec 2019
  2. Study start1 Sep 2019
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Jun 2022 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
464 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200781
Sponsor's protocol ID
19401972800
Status last verified
Dec 2019
First submitted
6 Dec 2019
Last updated
16 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arima H, Heeley E, Delcourt C, Hirakawa Y, Wang X, Woodward M, Robinson T, Stapf C, Parsons M, Lavados PM, Huang Y, Wang J, Chalmers J, Anderson CS; INTERACT2 Investigators; INTERACT2 Investigators. Optimal achieved blood pressure in acute intracerebral hemorrhage: INTERACT2. Neurology. 2015 Feb 3;84(5):464-71. doi: 10.1212/WNL.0000000000001205. Epub 2014 Dec 31.

    PubMed 25552575

  • Cai M, Yu Z, Zhang W, Yang L, Xiang J, Zhang J, Zhang Z, Wu T, Li X, Fu M, Bao X, Yu X, Cai D. Sheng-Di-Da-Huang Decoction Inhibited Inflammation Expressed in Microglia after Intracerebral Hemorrhage in Rats. Evid Based Complement Alternat Med. 2018 Oct 18;2018:6470534. doi: 10.1155/2018/6470534. eCollection 2018.

    PubMed 30498516

  • Chang JJ, Emanuel BA, Mack WJ, Tsivgoulis G, Alexandrov AV. Matrix metalloproteinase-9: dual role and temporal profile in intracerebral hemorrhage. J Stroke Cerebrovasc Dis. 2014 Nov-Dec;23(10):2498-2505. doi: 10.1016/j.jstrokecerebrovasdis.2014.07.005. Epub 2014 Oct 11.

    PubMed 25306400

  • Behrouz R, Azarpazhooh MR, Godoy DA, Hoffmann MW, Masotti L, Parry-Jones AR, Popa-Wagner A, Schreuder FH, Slevin MA, Smith CJ, Di Napoli M; MNEMONICH Steering Committee. The Multi-National survey on Epidemiology, Morbidity, and Outcomes iN Intracerebral Haemorrhage (MNEMONICH). Int J Stroke. 2015 Dec;10(8):E86. doi: 10.1111/ijs.12629. No abstract available.

    PubMed 26745705

  • Cordonnier C, Demchuk A, Ziai W, Anderson CS. Intracerebral haemorrhage: current approaches to acute management. Lancet. 2018 Oct 6;392(10154):1257-1268. doi: 10.1016/S0140-6736(18)31878-6.

    PubMed 30319113

  • Ding R, Chen Y, Yang S, Deng X, Fu Z, Feng L, Cai Y, Du M, Zhou Y, Tang Y. Blood-brain barrier disruption induced by hemoglobin in vivo: Involvement of up-regulation of nitric oxide synthase and peroxynitrite formation. Brain Res. 2014 Jul 7;1571:25-38. doi: 10.1016/j.brainres.2014.04.042. Epub 2014 May 9.

    PubMed 24814387

  • Flower O, Smith M. The acute management of intracerebral hemorrhage. Curr Opin Crit Care. 2011 Apr;17(2):106-14. doi: 10.1097/MCC.0b013e328342f823.

    PubMed 21169826

  • Garg R, Biller J. Recent advances in spontaneous intracerebral hemorrhage. F1000Res. 2019 Mar 18;8:F1000 Faculty Rev-302. doi: 10.12688/f1000research.16357.1. eCollection 2019.

    PubMed 30906532

  • Geng X, Ren C, Wang T, Fu P, Luo Y, Liu X, Yan F, Ling F, Jia J, Du H, Ji X, Ding Y. Effect of remote ischemic postconditioning on an intracerebral hemorrhage stroke model in rats. Neurol Res. 2012 Mar;34(2):143-8. doi: 10.1179/1743132811Y.0000000073. Epub 2012 Jan 13.

    PubMed 22333136

  • Gregson BA, Mitchell P, Mendelow AD. Surgical Decision Making in Brain Hemorrhage. Stroke. 2019 May;50(5):1108-1115. doi: 10.1161/STROKEAHA.118.022694.

    PubMed 30932784

  • Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, Mayo SW, Mendelow AD, Gregson B, Butcher K, Vespa P, Wright DW, Kase CS, Carhuapoma JR, Keyl PM, Diener-West M, Muschelli J, Betz JF, Thompson CB, Sugar EA, Yenokyan G, Janis S, John S, Harnof S, Lopez GA, Aldrich EF, Harrigan MR, Ansari S, Jallo J, Caron JL, LeDoux D, Adeoye O, Zuccarello M, Adams HP Jr, Rosenblum M, Thompson RE, Awad IA; CLEAR III Investigators. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017 Feb 11;389(10069):603-611. doi: 10.1016/S0140-6736(16)32410-2. Epub 2017 Jan 10.

    PubMed 28081952

  • Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.

    PubMed 30739747

  • Hao S, Wang B. Editorial: Review on Intracerebral Haemorrhage: Multidisciplinary Approaches to the Injury Mechanism Analysis and Therapeutic Strategies. Curr Pharm Des. 2017;23(15):2159-2160. doi: 10.2174/1381612823999170307150448. No abstract available.

    PubMed 28703081

  • Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.

    PubMed 18480205

  • Morotti A, Brouwers HB, Romero JM, Jessel MJ, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Greenberg SM, Martin RH, Qureshi AI, Rosand J, Goldstein JN; Antihypertensive Treatment of Acute Cerebral Hemorrhage II and Neurological Emergencies Treatment Trials Investigators. Intensive Blood Pressure Reduction and Spot Sign in Intracerebral Hemorrhage: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2017 Aug 1;74(8):950-960. doi: 10.1001/jamaneurol.2017.1014.

    PubMed 28628707

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Granules of Shengdi Dahuang Decoction in people with Hemorrhagic Stroke, run by ShuGuang Hospital at 5 sites in China.

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 6 inclusion and 12 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Xiaoyu Yu (86-021-20256378, doctorxiaoyu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability rate (time frame: 90 days). The study lists 2 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 NCT04200781, which also lists 22 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 16 Dec 2019.

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