Healthy ParticipantsPhase 1NCT04471298
A Study of Qishenyiqi Dripping Pills in Healthy Participants
A Phase 1 study testing Qishenyiqi dripping pills, 6 bags, Qishenyiqi dripping pills, 9 bags and Qishenyiqi dripping pills, 12 bags in people with Healthy Participants, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
This study will evaluate the safety and tolerability of Qishenyiqi Dripping Pills in healthy participants, following oral administration with multiple escalating dose of it. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Qishenyiqi dripping pills, 6 bags, Qishenyiqi dripping pills, 9 bags and Qishenyiqi dripping pills, 12 bags
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2020to 11 Jan 2021
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, male or female, aged 18-50 years (including the boundary value);
- Participants weigh at least 50.0 kg in male and 45.0 kg in female with a body mass index of all subjects between 19 and 26kg/m2 (including the boundary value);
- Participants are willing to have no pregnancy program and take effective contraceptive measures voluntarily since signing informed consent form to 3 months after the last administration;
- Participants are willing to sign Independent Ethics Committee (IEC)-approved informed consent form and able to understand and comply with study procedures.
Who cannot join
- Participants with allergic constitution or have a history of allergy to drug or food;
- Participants with diseases or physiological conditions that may affect the study, including but not limited to diseases of the nervous, mental, respiratory, cardiovascular, digestive, blood and lymphatic, endocrine, musculoskeletal systems, liver and kidney dysfunction;
- Participants who have any clinically significant abnormalities in vital signs, physical examination, electrocardiogram, chest radiograph, abdominal ultrasound and laboratory examination;
- Participants who have positive test for hepatitis B virus surface antigen (except surface antibodies), hepatitis C virus antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
- Women who are in the state of pregnancy or lactation;
- Participants who have a history of drug abuse or a positive test result for drug abuse at screening;
Show all 13Show fewer
- Participants who have smoked more than 5 cigarette per day or used a considerable amount of nicotine-containing products within the previous 3 months, and could not quit smoking during the experiment;
- Participants who have been drinking more than 14 units of alcohol per week within the previous 3 months (1 unit ≈285 mL beer with 3.5% alcohol or 25 mL spirits with 40% alcohol or 85 mL wines with 12% alcohol), or positive test for alcohol, or could not abstain from drinking during the trial;
- Participants who have taken any prescription drugs (including prescription, nonprescription, herbal medicine, dietary supplement such as vitamin product and calcium tablet) within 4 weeks before administration of investigational drugs;
- Participants who have difficulty in venous blood collection or history of fainting blood or needles;
- Participants who have participated in any drug clinical trial within 3 months and have taken the experimental drug or plan to participate in other clinical trials during the trial period;
- Participants who have donated or lost blood ≥200 mL within 3 months or received blood transfusion or used blood products, or have blood donation plan during the trial period;
- Judged by the investigator, participants have poor compliance or have other factors such as clinical, social or family that should not be included in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Teaching Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study to Evaluate the Safety and Tolerability of Continuous Oral Treatment With Qishenyiqi Dripping Pills in Healthy Participants
This study will evaluate the safety and tolerability of Qishenyiqi Dripping Pills in healthy participants, following oral administration with multiple escalating dose of it.
Read the detailed description
Qishenyiqi dripping pills, which are made of Huangqi, Danshen, Sanqi, active ingredients of Jiangxiang, have the efficacy of beneficial effects of qi and pulse, blood circulation and pain relief.
This study is a randomized, double-blind, placebo-controlled, dose-escalation design study, including three cohorts and 36 healthy participants. Within each cohort, participant will receive Qishenyiqi dripping pills at the selected dose level by oral administration three times a day for 28 consecutive days.
- Conditions
- Healthy Participants
- Being tested
- Qishenyiqi dripping pills, 6 bags, Qishenyiqi dripping pills, 9 bags, Qishenyiqi dripping pills, 12 bags, Qishenyiqi dripping pills placebo, 6 bags, Qishenyiqi dripping pills placebo, 9 bags
- Keywords
- Qishenyiqi Dripping Pills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishenyiqi dripping pills, 6 bagsDrug
28 consecutive days
Qishenyiqi dripping pills, 9 bagsDrug
28 consecutive days
Qishenyiqi dripping pills, 12 bagsDrug
28 consecutive days
Qishenyiqi dripping pills placebo, 6 bagsDrug
28 consecutive days
Qishenyiqi dripping pills placebo, 9 bagsDrug
28 consecutive days
Qishenyiqi dripping pills placebo, 12 bagsDrug
28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Active dosage group 1 | Active comparator | Qishenyiqi dripping pills, 3.12g, oral, three times a day Receives: Drug: Qishenyiqi dripping pills, 6 bags |
| Active dosage group 2 | Active comparator | Qishenyiqi dripping pills, 4.68g, oral, three times a day Receives: Drug: Qishenyiqi dripping pills, 9 bags |
| Active dosage group 3 | Active comparator | Qishenyiqi dripping pills, 6.24g, oral, three times a day Receives: Drug: Qishenyiqi dripping pills, 12 bags |
| Control dosage group 1 | Placebo comparator | Qishenyiqi dripping pills placebo, 3.12g, oral, three times a day Receives: Drug: Qishenyiqi dripping pills placebo, 6 bags |
| Control dosage group 2 | Placebo comparator | Qishenyiqi dripping pills placebo, 4.68g, oral, three times a day Receives: Drug: Qishenyiqi dripping pills placebo, 9 bags |
| Control dosage group 3 | Placebo comparator | Qishenyiqi dripping pills placebo, 6.24g, oral, three times a day Receives: Drug: Qishenyiqi dripping pills placebo, 12 bags |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Observe all the adverse events of all participants administrated orally with Qishenyiqi dripping pills.
Measured: From screening (2 weeks in advance) till follow-up visit (up to 1week)
Number of participants with abnormal vital signs index (body temperature)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: From screening (2 weeks in advance) till the end of trial period (Day 29)
Number of participants with abnormal vital signs index (pulse rate)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: From screening (2 weeks in advance) till the end of trial period (Day 29)
Number of participants with abnormal vital signs index (respiratory rate)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: From screening (2 weeks in advance) till the end of trial period (Day 29)
Number of participants with abnormal vital signs index (blood pressure)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: From screening (2 weeks in advance) till the end of trial period (Day 29)
Physical examination
The complete physical examinations will include an assessment of the general appearance, skin, cardiovascular, abdomen, head, and neck, lymph nodes, musculoskeletal and neurological systems.
Measured: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
Number of participants with abnormal laboratory assessments (blood routine test)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
Number of participants with abnormal laboratory assessments (blood biochemical test)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
Number of participants with abnormal laboratory assessments (coagulation function test)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
Number of participants with abnormal laboratory assessments (urinalysis routine test)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
Number of participants with abnormal laboratory assessments (fecal routine test)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
Number of participants with abnormal findings in 12-lead safety Electrocardiogram (ECG)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Measured: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start21 Sep 2020
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471298
- Sponsor's protocol ID
- TSL-TCM-QSYQDW-I
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2020
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study to Evaluate the Safety and Tolerability of Continuous Oral Treatment With Qishenyiqi Dripping Pills in Healthy Participants
- ClinicalTrials.gov ID
- NCT04471298
- Acronym / sponsor ID
- TSL-TCM-QSYQDW-I
- Conditions
- Healthy Participants
- Keywords
- Qishenyiqi Dripping Pills
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 15 Jul 2020 (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 will evaluate the safety and tolerability of Qishenyiqi Dripping Pills in healthy participants, following oral administration with multiple escalating dose of it.
Detailed description
Qishenyiqi dripping pills, which are made of Huangqi, Danshen, Sanqi, active ingredients of Jiangxiang, have the efficacy of beneficial effects of qi and pulse, blood circulation and pain relief.
This study is a randomized, double-blind, placebo-controlled, dose-escalation design study, including three cohorts and 36 healthy participants. Within each cohort, participant will receive Qishenyiqi dripping pills at the selected dose level by oral administration three times a day for 28 consecutive days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Active dosage group 1 | Active comparator | Drug: Qishenyiqi dripping pills, 6 bagsQishenyiqi dripping pills, 3.12g, oral, three times a day |
| Active dosage group 2 | Active comparator | Drug: Qishenyiqi dripping pills, 9 bagsQishenyiqi dripping pills, 4.68g, oral, three times a day |
| Active dosage group 3 | Active comparator | Drug: Qishenyiqi dripping pills, 12 bagsQishenyiqi dripping pills, 6.24g, oral, three times a day |
| Control dosage group 1 | Placebo comparator | Drug: Qishenyiqi dripping pills placebo, 6 bagsQishenyiqi dripping pills placebo, 3.12g, oral, three times a day |
| Control dosage group 2 | Placebo comparator | Drug: Qishenyiqi dripping pills placebo, 9 bagsQishenyiqi dripping pills placebo, 4.68g, oral, three times a day |
| Control dosage group 3 | Placebo comparator | Drug: Qishenyiqi dripping pills placebo, 12 bagsQishenyiqi dripping pills placebo, 6.24g, oral, three times a day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers, male or female, aged 18-50 years (including the boundary value);
- Participants weigh at least 50.0 kg in male and 45.0 kg in female with a body mass index of all subjects between 19 and 26kg/m2 (including the boundary value);
- Participants are willing to have no pregnancy program and take effective contraceptive measures voluntarily since signing informed consent form to 3 months after the last administration;
- Participants are willing to sign Independent Ethics Committee (IEC)-approved informed consent form and able to understand and comply with study procedures.
Key exclusion criteria (13 listed)
- Participants with allergic constitution or have a history of allergy to drug or food;
- Participants with diseases or physiological conditions that may affect the study, including but not limited to diseases of the nervous, mental, respiratory, cardiovascular, digestive, blood and lymphatic, endocrine, musculoskeletal systems, liver and kidney dysfunction;
- Participants who have any clinically significant abnormalities in vital signs, physical examination, electrocardiogram, chest radiograph, abdominal ultrasound and laboratory examination;
- Participants who have positive test for hepatitis B virus surface antigen (except surface antibodies), hepatitis C virus antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
- Women who are in the state of pregnancy or lactation;
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 |
|---|---|---|
| Qishenyiqi dripping pills, 6 bags28 consecutive days | Drug | Active dosage group 1 |
| Qishenyiqi dripping pills, 9 bags28 consecutive days | Drug | Active dosage group 2 |
| Qishenyiqi dripping pills, 12 bags28 consecutive days | Drug | Active dosage group 3 |
| Qishenyiqi dripping pills placebo, 6 bags28 consecutive days | Drug | Control dosage group 1 |
| Qishenyiqi dripping pills placebo, 9 bags28 consecutive days | Drug | Control dosage group 2 |
| Qishenyiqi dripping pills placebo, 12 bags28 consecutive days | Drug | Control dosage group 3 |
Primary outcome
Adverse events
Time frame: From screening (2 weeks in advance) till follow-up visit (up to 1week)
Observe all the adverse events of all participants administrated orally with Qishenyiqi dripping pills.
Number of participants with abnormal vital signs index (body temperature)
Time frame: From screening (2 weeks in advance) till the end of trial period (Day 29)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Number of participants with abnormal vital signs index (pulse rate)
Time frame: From screening (2 weeks in advance) till the end of trial period (Day 29)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Number of participants with abnormal vital signs index (respiratory rate)
Time frame: From screening (2 weeks in advance) till the end of trial period (Day 29)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Number of participants with abnormal vital signs index (blood pressure)
Time frame: From screening (2 weeks in advance) till the end of trial period (Day 29)
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Physical examination
Time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
The complete physical examinations will include an assessment of the general appearance, skin, cardiovascular, abdomen, head, and neck, lymph nodes, musculoskeletal and neurological systems.
Number of participants with abnormal laboratory assessments (blood routine test)
Time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Number of participants with abnormal laboratory assessments (blood biochemical test)
Time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Number of participants with abnormal laboratory assessments (coagulation function test)
Time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Number of participants with abnormal laboratory assessments (urinalysis routine test)
Time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Number of participants with abnormal laboratory assessments (fecal routine test)
Time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
Number of participants with abnormal findings in 12-lead safety Electrocardiogram (ECG)
Time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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 14 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Qishenyiqi dripping pills, 6 bags, Qishenyiqi dripping pills, 9 bags and Qishenyiqi dripping pills, 12 bags in people with Healthy Participants, run by Tasly Pharmaceutical Group Co., Ltd 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 4 inclusion and 13 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 14 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events (time frame: From screening (2 weeks in advance) till follow-up visit (up to 1week)). The study lists 12 primary outcomes in all. 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 14 Jul 2021.