GastritisPhase 2CTNCT04672018
Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
A Phase 2 study testing Houtou Jianweiling tablet and Omeprazole Tablet in people with Gastritis, run by University of Karachi at 1 site in Pakistan.
Trial summary
To study the efficacy \& safety of Houtou Jianweiling tablet through the non-inferiority clinical trial of Houtou Jianweiling tablet with Omeprazole Enteric-coated tablet in patients with chronic non-atrophic gastritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastritis
- What is being tested?
- Houtou Jianweiling tablet and Omeprazole Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Nov 2022to 2 Feb 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Comply with the diagnostic criteria for chronic non-atrophic gastritis.
- (2) Age between 18 to 65 years.
- (3) Voluntarily participate the clinical trials and sign informed consent.
Who cannot join
- (1) Subjects with history of gastric surgery.
- (2) Patients with complicated and special types of gastritis, peptic ulcer, hemorrhage, cholecystitis, cholelithiasis, dysplasia of gastric mucosa or pathological diagnosis of suspected malignant change.
- (3) Patients with atrophy and/or intestinal metaplasia through pathological examination showed;.
- (4) Severe primary diseases associated with cardiovascular, cerebrovascular, lung, liver, kidney and hematopoietic system (above grade II of cardiac function; Cr value above the upper limit of normal value), or serious diseases affecting their survival, such as cancer or AIDS;
- (5) Patients who have used Chinese and Western medicine to treat chronic non-atrophic gastritis in the last two weeks;
- (6) Subjects with psychiatric disorders or a history of alcohol/drug abuse;
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- (7) Pregnant women, woman who are preparing for pregnancy, lactating women;
- (8) Patients who are allergic constitution or allergic to known ingredients of test drugs;
- (9) Those who have participated in or are participating in other drug clinical trials in the past 3 months;
- (10) The syndrome differentiation is not clear or there are too many and complicated syndromes for the subjects;
- (11) Subjects that researchers do not consider appropriate to participate in clinical trials.
- (12) Patients with poor compliance are not allowed to participate in this trial.
- Those who meet one or more of the above exclusion criteria cannot be included in the clinical trial.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, 75270
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
To study the efficacy \& safety of Houtou Jianweiling tablet through the non-inferiority clinical trial of Houtou Jianweiling tablet with Omeprazole Enteric-coated tablet in patients with chronic non-atrophic gastritis.
Read the detailed description
This is a Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis.
- Conditions
- Gastritis
- Being tested
- Houtou Jianweiling tablet, Omeprazole Tablet
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Houtou Jianweiling tabletOther
Also called Traditional Chinese Medicine (TCM)
Houtou Jianweiling tablet (0.38 g), 4 tablets taken orally at a time, 3 times a day and Omeprazole Enteric-coated placebo tablet, taken 1 tablet orally once a day before breakfast.
Omeprazole TabletDrug
Also called Active comparator
Omeprazole Enteric-coated tablet (20 mg), 1 tablet taken orally once a day before breakfast and Houtou Jianweiling placebo tablets, taken orally, 4 tablets at a time, 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Test group (Houtou Jianeweiling tablet ) | Experimental | Houtou Jianweiling tablet (0.38 g), 4 tablets taken orally at a time, 3 times a day and Omeprazole Enteric-coated placebo tablet, taken 1 tablet orally once a day before breakfast. Receives: Other: Houtou Jianweiling tablet |
| Control group (Omeprazole enteric-coated tablet) | Active comparator | Omeprazole Enteric-coated tablet (20 mg), 1 tablet taken orally once a day before breakfast and Houtou Jianweiling placebo tablets, taken orally, 4 tablets at a time, 3 times a day. Receives: Drug: Omeprazole Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement rate of main Clinical symptoms
Gastric pain assessment（VAS score): Applying the Visual Analogue Scale (VAS) i.e. 0-10 Numeric Pain Intensity Scale on a 10 cm line segment, 0 is painless, 10 is extremely painful, patients will marked in the corresponding position according to the degree of pain, and the amount of the researcher give a specific score. The grading criteria of gastralgia with VAS score will be, normal: 0 cm; mild: 1-3 cm; moderate: 4-6 cm; severe: 7-10 cm.
Measured: During the four-week trial period
Physicians Global Assessment to measure quality of life (PGA)
Therapeutic efficacy evaluation by primary symptoms i.e. Gastric Distension on 0-6 points scoring system e.g.
0 point: None before treatment or disappeared after treatment 2 points: Slight gastric distension, from time to time, does not affect work and rest.
4 points: Gastric distension can be tolerable, attacks frequently, affecting work and rest.
6 points: The gastric distension is intolerable and persist for a long time. Often needs pain killer to relief pain.
Measured: During the four-week trial period
Secondary outcomes (7)
Laboratory examinations
Routine blood tests for liver function (alanine aminotransferase ALT, aspartate aminotransferase AST, gama γ-glutamyltransferase GGT, alkaline phosphatase ALP, total bilirubin T.BIL), Renal Function tests (BUN, Cr)
Measured: before enrollment and within 5 days after treatment
Pulse rate measurement
The Pulse rate of patients will be measured at different times
Measured: During the 4 weeks treatment period
Respiration rate measurement
The Respiration rate of patients will be measured at different times
Measured: During the 4 weeks treatment period
Blood Pressure measurement
Systolic and Diastolic blood pressure of patients will be measured at different times
Measured: During the 4 weeks treatment period
Body Temperature measurement
The Body Temperature of patients will be measured at different times
Measured: During the 4 weeks treatment period
Electrocardiogram
ECG QT Interval evaluation
Measured: before enrollment and within 5 days after treatment
Stool test for H. Pylori
Stool antigen test for H. Pylori detection
Measured: within 5 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start8 Nov 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Xinhui Pharmacy Limited Company
- Responsible party
- Principal investigator, Dr. Muhammad Raza Shah, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672018
- Sponsor's protocol ID
- CRO-002-TCM-HTJWT-2019
- Acronym
- CT
- Status last verified
- Apr 2023
- First submitted
- 28 Nov 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah MR, Fatima S, Khan SN, Shafiullah, Azam Z, Shaikh H, Majid S, Chengdong H, Daijun Z, Wang W. The safety and efficacy of Houtou Jianweiling tablet in patients with chronic non-atrophic gastritis: a double-blind, non-inferiority, randomized controlled trial. Front Pharmacol. 2024 Feb 19;15:1293272. doi: 10.3389/fphar.2024.1293272. eCollection 2024.
PubMed 38440179
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
- ClinicalTrials.gov ID
- NCT04672018
- Acronym / sponsor ID
- CT / CRO-002-TCM-HTJWT-2019
- Conditions
- Gastritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Hunan Xinhui Pharmacy Limited Company
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 17 Dec 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.
To study the efficacy \& safety of Houtou Jianweiling tablet through the non-inferiority clinical trial of Houtou Jianweiling tablet with Omeprazole Enteric-coated tablet in patients with chronic non-atrophic gastritis.
Detailed description
This is a Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Test group (Houtou Jianeweiling tablet ) | Experimental | Other: Houtou Jianweiling tabletHoutou Jianweiling tablet (0.38 g), 4 tablets taken orally at a time, 3 times a day and Omeprazole Enteric-coated placebo tablet, taken 1 tablet orally once a day before breakfast. |
| Control group (Omeprazole enteric-coated tablet) | Active comparator | Drug: Omeprazole TabletOmeprazole Enteric-coated tablet (20 mg), 1 tablet taken orally once a day before breakfast and Houtou Jianweiling placebo tablets, taken orally, 4 tablets at a time, 3 times a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) Comply with the diagnostic criteria for chronic non-atrophic gastritis.
- (2) Age between 18 to 65 years.
- (3) Voluntarily participate the clinical trials and sign informed consent.
Key exclusion criteria (13 listed)
- (1) Subjects with history of gastric surgery.
- (2) Patients with complicated and special types of gastritis, peptic ulcer, hemorrhage, cholecystitis, cholelithiasis, dysplasia of gastric mucosa or pathological diagnosis of suspected malignant change.
- (3) Patients with atrophy and/or intestinal metaplasia through pathological examination showed;.
- (4) Severe primary diseases associated with cardiovascular, cerebrovascular, lung, liver, kidney and hematopoietic system (above grade II of cardiac function; Cr value above the upper limit of normal value), or serious diseases affecting their survival, such as cancer or AIDS;
- (5) Patients who have used Chinese and Western medicine to treat chronic non-atrophic gastritis in the last two weeks;
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 |
|---|---|---|
| Houtou Jianweiling tabletAlso: Traditional Chinese Medicine (TCM)Houtou Jianweiling tablet (0.38 g), 4 tablets taken orally at a time, 3 times a day and Omeprazole Enteric-coated placebo tablet, taken 1 tablet orally once a day before breakfast. | Other | Test group (Houtou Jianeweiling tablet ) |
| Omeprazole TabletAlso: Active comparatorOmeprazole Enteric-coated tablet (20 mg), 1 tablet taken orally once a day before breakfast and Houtou Jianweiling placebo tablets, taken orally, 4 tablets at a time, 3 times a day. | Drug | Control group (Omeprazole enteric-coated tablet) |
Primary outcome
The improvement rate of main Clinical symptoms
Time frame: During the four-week trial period
Gastric pain assessment（VAS score): Applying the Visual Analogue Scale (VAS) i.e. 0-10 Numeric Pain Intensity Scale on a 10 cm line segment, 0 is painless, 10 is extremely painful, patients will marked in the corresponding position according to the degree of pain, and the amount of the researcher give a specific score. The grading criteria of gastralgia with VAS score will be, normal: 0 cm; mild: 1-3 cm; moderate: 4-6 cm; severe: 7-10 cm.
Physicians Global Assessment to measure quality of life (PGA)
Time frame: During the four-week trial period
Therapeutic efficacy evaluation by primary symptoms i.e. Gastric Distension on 0-6 points scoring system e.g. 0 point: None before treatment or disappeared after treatment 2 points: Slight gastric distension, from time to time, does not affect work and rest. 4 points: Gastric distension can be tolerable, attacks frequently, affecting work and rest. 6 points: The gastric distension is intolerable and persist for a long time. Often needs pain killer to relief pain.
7 secondary outcomes
Laboratory examinations
Time frame: before enrollment and within 5 days after treatment
Pulse rate measurement
Time frame: During the 4 weeks treatment period
Respiration rate measurement
Time frame: During the 4 weeks treatment period
Blood Pressure measurement
Time frame: During the 4 weeks treatment period
Body Temperature measurement
Time frame: During the 4 weeks treatment period
Electrocardiogram
Time frame: before enrollment and within 5 days after treatment
Stool test for H. Pylori
Time frame: within 5 days after treatment
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 18 Apr 2023.
- Derived from this study: PubMed 38440179Shah MR, Fatima S, Khan SN, Shafiullah, Azam Z, Shaikh H, Majid S, Chengdong H, Daijun Z, Wang W. The safety and efficacy of Houtou Jianweiling tablet in patients with chronic non-atrophic gastritis: a double-blind, non-inferiority, randomized controlled trial. Front Pharmacol. 2024 Feb 19;15:1293272. doi: 10.3389/fphar.2024.1293272. eCollection 2024.
- 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.
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 2 study testing Houtou Jianweiling tablet and Omeprazole Tablet in people with Gastritis, run by University of Karachi at 1 site in Pakistan.
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 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 18 Apr 2023. 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 Pakistan. 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. 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?
The improvement rate of main Clinical symptoms (time frame: During the four-week trial period). 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 NCT04672018, which also lists 1 linked publication.
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 18 Apr 2023.