Amyotrophic Lateral SclerosisPhase 2/3NCT04950933
The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules
A Phase 2/3 study testing Huolingshengji Granules and Riluzole tablet in people with Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study intends to evaluate the efficacy and safety of Dong Lingsheng Ji Granule in the treatment of amyotrophic lateral sclerosis (spleen deficiency, kidney-yang deficiency syndrome) in comparison with riluzole, so as to provide data support for marketing application or subsequent clinical research design. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Huolingshengji Granules and Riluzole tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Dec 2022
- Phase
- Phase 2/3
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the Western diagnostic criteria for amyotrophic lateral sclerosis (ALS) (clinically confirmed ALS, clinically likely ALS or clinically likely ALS- laboratory support);
- The score of the modified amyotrophic lateral sclerosis function scale (ALSFRS-R) was ≥2 points for each item (among which dyspnea, sitting breathing and respiratory insufficiency were all 4 points);
- The percentage of forced vital capacity in the predicted value (FVC%) ≥70%;
- the duration of the disease is 3 years or less (from the first onset of any symptoms of ALS);
- TCM syndrome differentiation for deficiency of temper, kidney Yang deficiency syndrome;
- Age 45-70 (including 45 and 70), gender unlimited;
- Voluntarily participate in the clinical trial, give informed consent and sign informed consent.
- Exclusion Criteria:(1) Patients diagnosed with familial ALS; (2) Those who have undergone gastrostomy; (3) patients with other neurological diseases similar to ALS, such as cervical spondylotic myelopathy, lumbar spondylopathy, dementia, etc., which may affect the evaluation of drug effectiveness; (4) electromyogram detection found motor nerve conduction block, sensory nerve conduction abnormality, imaging examination (CT or MRI) found that can explain the clinical manifestations of substantial lesions; (5) Patients who had been treated with riluzole or edaravone within 3 months before enrollment; (6) patients with a history of spinal surgery after the onset of ALS; (7) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 times the upper limit of the normal reference value, or blood muscle (SCR) >; Upper limit of normal reference value; (8) Patients with other serious primary diseases of the nervous system, heart, lung, hematopoietic system or endocrine system and psychosis; (9) Suspected or have a history of alcohol and drug abuse; (10) Pregnant women or lactating women, subjects of reproductive age (including male subjects with heterosexual behavior and their female partners with fertility potential) have pregnancy plans or are unwilling to take effective contraceptive measures within 3 months from the beginning of screening to the end of drug withdrawal; (11) People who are known or suspected to have a history of allergy to the test drug and its excipients; (12) Screening participants who had participated in other clinical trials within the previous 3 months; (13) Those considered by the researcher to be unsuitable to participate in this clinical trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijin
Dongsheng Fan, 13701023871, dsfan@sina.com
About this study
Official title: A Multi-center, Randomized, Double-blind, Positives Parallel Controlled, Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of Huollingshengji Granules in the Treatment of Amyotrophic Lateral Sclerosis (Spleen qi Deficiency, Kidney Yang Deficiency Syndrome)
This study intends to evaluate the efficacy and safety of Dong Lingsheng Ji Granule in the treatment of amyotrophic lateral sclerosis (spleen deficiency, kidney-yang deficiency syndrome) in comparison with riluzole, so as to provide data support for marketing application or subsequent clinical research design.
Read the detailed description
This study proposed the multicenter, randomized, double-blind, double simulation, positive drug parallel contrast the bad effect of experimental design, into the treatment group 72 cases, control group of 72 cases with the azole comparison, evaluation Dong Ling raw grain treatment on muscle atrophy amyotrophic lateral sclerosis (lack of temper, kidney Yang deficiency syndrome) efficacy and safety, for applications or follow-up clinical study design to provide data support.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Huolingshengji Granules, Riluzole tablet
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huolingshengji GranulesDrug
1 bag of Huolingshengji Granules each time + 1 tablet of Riluzole tablet simulation agent each time, twice a day, orally;
Riluzole tabletDrug
Huolingshengji granules simulation agent 1 bag each time + Riluzole tablet 1 tablet each time, 2 times a day, orally.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Drug: Huolingshengji Granules |
| Control group | Placebo comparator | Not described Receives: Drug: Riluzole tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALSFRS-R scores
Changes in ALSFRS-R scores from baseline after 48 weeks of treatment, The ALSFRS-R scale (ALS Functional Rating Scale) includes 12 items including medulla oblongata function, limb function and respiratory function, with a total score of 48. The lower the score, the more serious the neurological function damage.
Measured: 48 weeks
Secondary outcomes (1)
FVC%
Change in FVC% from baseline after 48 weeks of treatment
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University
- Responsible party
- Sponsor
- Investigators
- Dongsheng Fan, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950933
- Sponsor's protocol ID
- D2020076
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Positives Parallel Controlled, Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of Huollingshengji Granules in the Treatment of Amyotrophic Lateral Sclerosis (Spleen qi Deficiency, Kidney Yang Deficiency Syndrome)
- ClinicalTrials.gov ID
- NCT04950933
- Acronym / sponsor ID
- D2020076
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jul 2021 (actual)
- 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.
This study intends to evaluate the efficacy and safety of Dong Lingsheng Ji Granule in the treatment of amyotrophic lateral sclerosis (spleen deficiency, kidney-yang deficiency syndrome) in comparison with riluzole, so as to provide data support for marketing application or subsequent clinical research design.
Detailed description
This study proposed the multicenter, randomized, double-blind, double simulation, positive drug parallel contrast the bad effect of experimental design, into the treatment group 72 cases, control group of 72 cases with the azole comparison, evaluation Dong Ling raw grain treatment on muscle atrophy amyotrophic lateral sclerosis (lack of temper, kidney Yang deficiency syndrome) efficacy and safety, for applications or follow-up clinical study design to provide data support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Huolingshengji Granules |
| Control group | Placebo comparator | Drug: Riluzole tablet |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the Western diagnostic criteria for amyotrophic lateral sclerosis (ALS) (clinically confirmed ALS, clinically likely ALS or clinically likely ALS- laboratory support);
- The score of the modified amyotrophic lateral sclerosis function scale (ALSFRS-R) was ≥2 points for each item (among which dyspnea, sitting breathing and respiratory insufficiency were all 4 points);
- The percentage of forced vital capacity in the predicted value (FVC%) ≥70%;
- the duration of the disease is 3 years or less (from the first onset of any symptoms of ALS);
- TCM syndrome differentiation for deficiency of temper, kidney Yang deficiency syndrome;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Huolingshengji Granules1 bag of Huolingshengji Granules each time + 1 tablet of Riluzole tablet simulation agent each time, twice a day, orally; | Drug | Test group |
| Riluzole tabletHuolingshengji granules simulation agent 1 bag each time + Riluzole tablet 1 tablet each time, 2 times a day, orally. | Drug | Control group |
Primary outcome
ALSFRS-R scores
Time frame: 48 weeks
Changes in ALSFRS-R scores from baseline after 48 weeks of treatment, The ALSFRS-R scale (ALS Functional Rating Scale) includes 12 items including medulla oblongata function, limb function and respiratory function, with a total score of 48. The lower the score, the more serious the neurological function damage.
1 secondary outcome
FVC%
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Dongsheng Fan principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Huolingshengji Granules and Riluzole tablet in people with Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site 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 8 inclusion and 0 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 8 Jul 2021. 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 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dongsheng Fan (+86 13701023871, dsfan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALSFRS-R scores (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2021.