Cervical Spondylotic MyelopathyPhase 3NCT06377072
Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy
A Phase 3 study testing Shenqi Sherong Pill in people with Cervical Spondylotic Myelopathy, run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- What is being tested?
- Shenqi Sherong Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2024to 14 Jan 2026
- Phase
- Phase 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants can only be selected if they meet all the inclusion criteria
- Age 18-75 years old (including 18 and 75 years old), gender unlimited;
- Accord with Western medicine diagnosis standards of Cervical Spondylotic Myelopathy;
- Accord with Chinese medicine diagnosis standards of qi deficiency, blood stasis and kidney deficiency type;
- The disease classification was mild or moderate (13 ≤mJOA score ≤15);
- X-ray examination of six cervical vertebrae (frontal, lateral, hyperextension and flexion lateral and double oblique) indicates cervical degenerative changes, while MRI examination indicates spinal cord compression;
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- The first diagnosis of Cervical Spondylotic Myelopathy within 3 months; for those diagnosed for more than 3 months, the investigator needs to determine that the condition is basically stable;
- Participants voluntarily participate in this experiment and sign an informed consent.
- Note: 1) CT examination is determined by the investigator according to the specific conditions of participants. 2) Imaging materials of MRI, X-ray(frontal, lateral, hyperextension and flexion and double oblique), CT examination within 3 months from the 3A Grade hospital can be accepted ; 3) If the laboratory tests and 12-lead electrocardiogram are completed in the research center on the same day before the participant signing an informed consent, the examination can not be repeated after the investigator judging.
Who cannot join
- Participants should be excluded if they meet any one exclusion criteria :
- The use of long-acting hormone drugs within 1 week before screening, or the last drug use is less than 7 half-lives, or Traditional Chinese Medicine, drugs with no marked half-life, physical therapy, etc. is less than 3 days before screening for the treatment of this disease;
- Participants with obvious concurrent syndrome or complication (such as Hypertension after taking antihypertensive drugs who systolic pressure ≥160mmHg, or diastolic pressure ≥100mmHg , or Diabetes after taking antidiabetic drugs who fasting blood glucose ≥10.0mmol/L and so on);
- MRI examination shows the degree of spinal stenosis is 1/2 or more, or the spinal cord compression caused by cervical spondylosis is three or more segments;
- Participants with severe hand muscle atrophy, or spasms, or is difficult to walk independently, or urinary dysfunction;
- Participants with cervical spine fracture, or congenital deformity of cervical spine, or ossification of ligamentum flavum, or ossification of posterior longitudinal ligament, or with neurological diseases such as lateral sclerosis and multiple sclerosis;
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- Participants with visual analogue scale(VAS) score >7 points (7 points is defined as the distance between the left end and the mark location equal to 7.0cm);
- Participants with severe heart disease, such as myocardial infarction, unstable angina pectoris, Ⅲ to Ⅳ congestive heart failure and severe arrhythmia according to New York Heart Association (NYHA),or with severe liver and kidney diseases, or with abnormal liver and kidney function tests (Alanine aminotransferase or Aspartate aminotransferase ≥ 1.5 times the upper limit of normal, or creatinine clearance> the upper limit of normal); or with severe lung disease such as chronic bronchitis, asthma, chronic obstructive pulmonary disease(COPD) and other acute episodes;
- Participants with cerebral infarction and serious mental disorders;
- Woman in lactation, pregnancy, or planned pregnancy;
- Participant is allergic constitution or known to be allergic to the components of the investigational drug;
- Participants have participated or are participating in other clinical trials within 3 months;
- Participants are judged unsuitable for participation by the investigators in the study.
- Note: 1) If examination or efficacy index score of visit 1 and visit 2 is overlapping item, the baseline standard is based on visit 2; 2) Participant who has the abnormal laboratory examination items during screening can be arranged for retest, whether to be enrolled or not will be comprehensively evaluated by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510000
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Shenqi Sherong Pill in Cervical Spondylotic Myelopathy (Qi Deficiency, Blood Stasis and Kidney Deficiency Type)
The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration.
Read the detailed description
- Trial Design： This is a multi-center, randomized, double-blind, placebo-controlled phase III study，which plans to enroll 428 participants who will be randomized to Shenqi Sherong pill group or placebo control group. The Modified Japanese Orthopaedic Association (mJOA) Score combined with the changes of clinical symptoms and syndrome score are used as the validity index. The laboratory examination and incidence of adverse events are used as the safety index.
- Therapeutic schedule： Participants will be provided with neck braces and recommended to wear them daily or outdoors along with health education. Participants will be treated with the investigational drug (Shenqi Sherong Pill or placebo ) by taking two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks, with a 2-week follow-up after withdrawal.
- Conditions
- Cervical Spondylotic Myelopathy
- Being tested
- Shenqi Sherong Pill, Placebo
- Keywords
- Qi deficiency, Blood stasis, Kidney deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenqi Sherong PillDrug
two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks
PlaceboDrug
two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Shenqi Sherong Pill | Experimental | 6g per bag Receives: Drug: Shenqi Sherong Pill |
| Placebo | Placebo comparator | 6g per bag Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Japanese Orthopaedic Association (mJOA) score
Change in Modified Japanese Orthopaedic Association (mJOA) score (on a scale from 0 to 18, with lower scores indicating greater disability) from baseline at Day 42 after administration; the mJOA which is a clinician administered scale to evaluate four clinical dimensions; motor dysfunction score for upper and lower extremities, sensation loss and sphincter dysfunction.
Measured: 42±2 days
Secondary outcomes (10)
Change in mJOA score
Changes in mJOA score (on a scale from 0 to 18, with lower scores indicating greater disability) from baseline at Day 14，Day 28 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 56±2 days
Change in sensation of mJOA score
Changes in sensation of mJOA score (on a scale from 0 to 3, with lower scores indicating greater disability) from baseline at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Changes in pain or stiffness score for neck and shoulder
Changes in pain or stiffness score (on a scale from 0 to10, with higher scores indicating greater pain) for neck and shoulder from baseline at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in chest tightness score
Change in chest tightness score (on a scale from 0 to10, with higher scores indicating greater tightness) from baseline at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Changes in hand and arm numbness scores
Changes in hand and arm numbness scores (on a scale from 0 to10, with higher scores indicating greater numbness) at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in numbness (or pain) scores from the chest to the toes
Changes from baseline in numbness (or pain) scores (on a scale from 0 to10, with higher scores indicating greater numbness or pain) from the chest to the toes at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in Motor dysfunction of the upper extremities of mJOA score
Change in Motor dysfunction of the upper extremities of mJOA score (on a scale from 0 to 5, with lower scores indicating greater disability) at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Proportion of participants with at least 1 grade decline in Nurick grades
Proportion of participants with at least 1 grade decline from baseline in Nurick grades (on a scale from 0 to 5, with higher scores indicating greater disability) at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in Traditional Chinese medicine (TCM) syndrome integrality
Change in Traditional Chinese medicine (TCM) syndrome integrality (on a scale from 0 to 9, with higher scores indicating greater seriousness) at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in TCM syndrome score
Change in TCM syndrome score (on a scale from 0 to 9, with higher scores indicating greater seriousness) at Day 14, Day 28, Day 42 and Day 56 after administration
Measured: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start11 May 2024
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spondylotic MyelopathyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bolai Chen, doctor, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377072
- Sponsor's protocol ID
- SHPL-W036-301
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Shenqi Sherong Pill in Cervical Spondylotic Myelopathy (Qi Deficiency, Blood Stasis and Kidney Deficiency Type)
- ClinicalTrials.gov ID
- NCT06377072
- Acronym / sponsor ID
- SHPL-W036-301
- Conditions
- Cervical Spondylotic Myelopathy
- Keywords
- Qi deficiency, Blood stasis, Kidney deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 May 2024 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 22 Apr 2024 (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.
The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration.
Detailed description
- Trial Design： This is a multi-center, randomized, double-blind, placebo-controlled phase III study，which plans to enroll 428 participants who will be randomized to Shenqi Sherong pill group or placebo control group. The Modified Japanese Orthopaedic Association (mJOA) Score combined with the changes of clinical symptoms and syndrome score are used as the validity index. The laboratory examination and incidence of adverse events are used as the safety index.
- Therapeutic schedule： Participants will be provided with neck braces and recommended to wear them daily or outdoors along with health education. Participants will be treated with the investigational drug (Shenqi Sherong Pill or placebo ) by taking two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks, with a 2-week follow-up after withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shenqi Sherong Pill | Experimental | Drug: Shenqi Sherong Pill6g per bag |
| Placebo | Placebo comparator | Drug: Placebo6g per bag |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants can only be selected if they meet all the inclusion criteria
- Age 18-75 years old (including 18 and 75 years old), gender unlimited;
- Accord with Western medicine diagnosis standards of Cervical Spondylotic Myelopathy;
- Accord with Chinese medicine diagnosis standards of qi deficiency, blood stasis and kidney deficiency type;
- The disease classification was mild or moderate (13 ≤mJOA score ≤15);
Key exclusion criteria (14 listed)
- The use of long-acting hormone drugs within 1 week before screening, or the last drug use is less than 7 half-lives, or Traditional Chinese Medicine, drugs with no marked half-life, physical therapy, etc. is less than 3 days before screening for the treatment of this disease;
- Participants with obvious concurrent syndrome or complication (such as Hypertension after taking antihypertensive drugs who systolic pressure ≥160mmHg, or diastolic pressure ≥100mmHg , or Diabetes after taking antidiabetic drugs who fasting blood glucose ≥10.0mmol/L and so on);
- MRI examination shows the degree of spinal stenosis is 1/2 or more, or the spinal cord compression caused by cervical spondylosis is three or more segments;
- Participants with severe hand muscle atrophy, or spasms, or is difficult to walk independently, or urinary dysfunction;
- Participants with cervical spine fracture, or congenital deformity of cervical spine, or ossification of ligamentum flavum, or ossification of posterior longitudinal ligament, or with neurological diseases such as lateral sclerosis and multiple sclerosis;
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 |
|---|---|---|
| Shenqi Sherong Pilltwo bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks | Drug | Shenqi Sherong Pill |
| Placebotwo bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks | Drug | Placebo |
Primary outcome
Change in Modified Japanese Orthopaedic Association (mJOA) score
Time frame: 42±2 days
Change in Modified Japanese Orthopaedic Association (mJOA) score (on a scale from 0 to 18, with lower scores indicating greater disability) from baseline at Day 42 after administration; the mJOA which is a clinician administered scale to evaluate four clinical dimensions; motor dysfunction score for upper and lower extremities, sensation loss and sphincter dysfunction.
10 secondary outcomes
Change in mJOA score
Time frame: 14±2 days, 28±2 days, 56±2 days
Change in sensation of mJOA score
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Changes in pain or stiffness score for neck and shoulder
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in chest tightness score
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Changes in hand and arm numbness scores
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in numbness (or pain) scores from the chest to the toes
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in Motor dysfunction of the upper extremities of mJOA score
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Proportion of participants with at least 1 grade decline in Nurick grades
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in Traditional Chinese medicine (TCM) syndrome integrality
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in TCM syndrome score
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
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 11 Sep 2026.
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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.
Bolai Chen, doctor principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shenqi Sherong Pill in people with Cervical Spondylotic Myelopathy, run by Shanghai Hutchison Pharmaceuticals Limited 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 9 inclusion and 14 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 11 Sep 2026. 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 phase mean?
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?
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 Modified Japanese Orthopaedic Association (mJOA) score (time frame: 42±2 days). 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 11 Sep 2026.