Atrophic VaginitisPhase 1NCT02733731
The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis
A Phase 1 study testing Chinese Herbal Compound Ointment and Estriol in people with Atrophic Vaginitis, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Objective：To evaluate the effect and safety of the traditional chinese medicine oil agent on senile atrophic compared as compared to estriol cream in aged woman. Design: A randomized double-blind controlled trial. Setting: The hospital ward. Participants: 200 postmenopausal woman with senile vaginitis (mean age 56). Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Atrophic Vaginitis
- What is being tested?
- Chinese Herbal Compound Ointment and Estriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jun 2016
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- With typical clinical manifestations: virginal genital itching or burning sense, Increased vaginal secretions, a yellow, a serious bloody pus-like leucorrhea, or sexual intercourse pain
- Gynecological examination: Vaginal epithelium atrophy，Vaginal folds flat or disappear， mucosal hyperemia， superficial ulceration
- Both ALT and AST are normal or less than 2 times, bilirubin is normal
- Serum creatinine level is within the normal range
- ECG is normal;
Who cannot join
- Gynecological and breast Oncology, endometrial hyperplasia(≥5mm)
- Estrogenic drugs or probiotics used in four week
- Participate in other clinical trials;Thrombotic diseases
- Abnormal vaginal bleeding without clear diagnose
- Estriol allergy
- Severe pneumonia, tuberculosis, lung abscess, myocarditis
- heart,liver or kidney failure(NYHA class III-IV,ALT to AST ratio twice more than upper limit of normal
- sexually transmitted diseases;mental disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun-yat Sen University
Guangzhou, Guangdong, 510000
Xin Zhou, master, 13533259616, myeva520@163.com
Bao-guo Sun, doctor, 13316134352, Sunbaoguo666@126.com
About this study
Objective：To evaluate the effect and safety of the traditional chinese medicine oil agent on senile atrophic compared as compared to estriol cream in aged woman.
Design: A randomized double-blind controlled trial.
Setting: The hospital ward.
Participants: 200 postmenopausal woman with senile vaginitis (mean age 56).
Intervention: The traditional chinese medicine oil and estriol cream were separately intravaginal administrated in treatment group and control group for 3 weeks，follow-up 1 month.
Measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall, vaginal discharge, and PH changes.
Read the detailed description
80 postmenopausal women living in the communities near the hospital with AV (atrophic vaginitis) symptoms were recruited for this clinical trial. Patients with AV receiving external treatment and requiring hospitalization were randomized in a double-blind, single-centre trial. Subjects received CHCO (Chinese Herbal Compound Ointment) topical vaginal application in experimental group, while estriol in control group. The dosage of medicine for single treatment once a day in two group is 0.5g.The total time for therapy is 3 weeks in two groups. Assessment indicators：vagine PH, sIgA and IL-1βchanges, the degree of symptoms improving, onset time, edema-size of vaginal wall, vaginal discharge, and relapses and retreatment effect.
- Conditions
- Atrophic Vaginitis
- Being tested
- Chinese Herbal Compound Ointment, Estriol
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal Compound OintmentDrug
EstriolDrug
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herbal Compound Ointment | Experimental | This kind of CHCO composed of several chinese herbs,dong quai,angelica,resina draconis and lithospermum.The dosage of medicine for single treatment once a day in two group is 0.5g,The total time for therapy is 3 weeks. Receives: Drug: Chinese Herbal Compound Ointment |
| Estriol | Active comparator | The dosage of medicine for single treatment once a day in two group is 0.5g,The total time for therapy is 3 weeks in two groups. Receives: Drug: Estriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom questionnaire scores
Measured: 77days
sign questionnaire scores
Measured: 77days
Secondary outcomes (5)
recurrence rate retreatment effect
Measured: Within 28days after treatment
retreatment effective rate
Measured: Within 56days after treatment
PH value of vaginae secretion
Measured: 49days
sIgA value of vaginae secretion
Measured: 49days
IL-1βvalue of vaginae secretion
Measured: 49days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic VaginitisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Xin, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733731
- Sponsor's protocol ID
- Zxin
- Status last verified
- Mar 2016
- First submitted
- 20 Mar 2016
- Last updated
- 11 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT02733731
- Acronym / sponsor ID
- Zxin
- Conditions
- Atrophic Vaginitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 11 Apr 2016 (estimated)
- 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.
Objective：To evaluate the effect and safety of the traditional chinese medicine oil agent on senile atrophic compared as compared to estriol cream in aged woman.
Design: A randomized double-blind controlled trial.
Setting: The hospital ward.
Participants: 200 postmenopausal woman with senile vaginitis (mean age 56).
Intervention: The traditional chinese medicine oil and estriol cream were separately intravaginal administrated in treatment group and control group for 3 weeks，follow-up 1 month.
Measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall, vaginal discharge, and PH changes.
Detailed description
80 postmenopausal women living in the communities near the hospital with AV (atrophic vaginitis) symptoms were recruited for this clinical trial. Patients with AV receiving external treatment and requiring hospitalization were randomized in a double-blind, single-centre trial. Subjects received CHCO (Chinese Herbal Compound Ointment) topical vaginal application in experimental group, while estriol in control group. The dosage of medicine for single treatment once a day in two group is 0.5g.The total time for therapy is 3 weeks in two groups. Assessment indicators：vagine PH, sIgA and IL-1βchanges, the degree of symptoms improving, onset time, edema-size of vaginal wall, vaginal discharge, and relapses and retreatment effect.
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 |
|---|---|---|
| Chinese Herbal Compound Ointment | Experimental | Drug: Chinese Herbal Compound OintmentThis kind of CHCO composed of several chinese herbs,dong quai,angelica,resina draconis and lithospermum.The dosage of medicine for single treatment once a day in two group is 0.5g,The total time for therapy is 3 weeks. |
| Estriol | Active comparator | Drug: EstriolThe dosage of medicine for single treatment once a day in two group is 0.5g,The total time for therapy is 3 weeks in two groups. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women
- With typical clinical manifestations: virginal genital itching or burning sense, Increased vaginal secretions, a yellow, a serious bloody pus-like leucorrhea, or sexual intercourse pain
- Gynecological examination: Vaginal epithelium atrophy，Vaginal folds flat or disappear， mucosal hyperemia， superficial ulceration
- Both ALT and AST are normal or less than 2 times, bilirubin is normal
- Serum creatinine level is within the normal range
Key exclusion criteria (8 listed)
- Gynecological and breast Oncology, endometrial hyperplasia(≥5mm)
- Estrogenic drugs or probiotics used in four week
- Participate in other clinical trials;Thrombotic diseases
- Abnormal vaginal bleeding without clear diagnose
- Estriol allergy
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 |
|---|---|---|
| Chinese Herbal Compound Ointment | Drug | Chinese Herbal Compound Ointment |
| Estriol | Drug | Estriol |
Primary outcome
symptom questionnaire scores
Time frame: 77days
sign questionnaire scores
Time frame: 77days
5 secondary outcomes
recurrence rate retreatment effect
Time frame: Within 28days after treatment
retreatment effective rate
Time frame: Within 56days after treatment
PH value of vaginae secretion
Time frame: 49days
sIgA value of vaginae secretion
Time frame: 49days
IL-1βvalue of vaginae secretion
Time frame: 49days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
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VALOR: Vaginal Atrophy & Long-term Observation of Recovery
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Not yet recruitingPhase 4
Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women
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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.
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 Chinese Herbal Compound Ointment and Estriol in people with Atrophic Vaginitis, run by First Affiliated Hospital, Sun Yat-Sen University 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 6 inclusion and 8 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 11 Apr 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Zhou, master (13533259616, myeva520@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom questionnaire scores (time frame: 77days). 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?
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 Apr 2016.