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PCOSPhase 2NCT03264638

A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS

A Phase 2 study testing Dingkundan, Dingkundan & Diane-35 and Diane-35 in people with PCOS, run by Aijun Sun at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in adults women. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
PCOS
What is being tested?
Dingkundan, Dingkundan & Diane-35 and Diane-35
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
1 siteChina
Study dates
1 Oct 2016to 31 Aug 2018
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject is a female between the age of 18 and 40.
  • Subject diagnosed as PCOS by the 2003 Rotterdam criteria.
  • Subject provides written informed consent.

Who cannot join

  • Subject has other endocrine diseases,such as adrenal hyperplasias or tumor, androgen-secreting tumours, Cushing's syndrome,thyroid diseases and hyperprolactinemia.
  • Subject has received related medical or surgical treatment in the past 3 months.
  • Subject suffered from substance abuse or dependence(such as alcohol or drugs);
  • Subject is a heavy smoker(reaching or more than 20 cigarettes a day).
  • Subject is pregnant or lactating or within 1 year after delivery.
  • Subject has a severe systemic disease, such as cardiovascular system
Show all 10Show fewer
  • Subject has a history of malignancy or radiotherapy.
  • Subject has an allergic history to the drugs used in the study.
  • Subject has mental disorder incapable of elementary cooperations.
  • Subject has participated in other clinical researches of medicine within 3 month prior to randomization.

Trial locations and contacts

1 site in 1 country.

Lei Li, MD contact

139-1198-8831 ext. +86

lileigh@163.com

China1 site, 1 recruiting

  • Lei Li

    Beijing, China/Beiing, 100000

    Lei L Li, MD, 13911988831 ext. +86, lileigh@163.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of Polycystic Ovary Syndrome

This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in adults women. One third of participants will receive Dingkundan capsules, one third of participants will receive Diane-35 Pills, and the another third will receive Dingkundan capsules and Diane-35 in combination.

Read the detailed description

Dingkundan,Diane-35 each ameliorate PCOS, but they do so by different mechanisms. We generally treat PCOS patients without immediate fertility requirement by short-acting contraceptives,Diane-35 is one of the most commonly used drugs.

Dingkundan consists of multiple chinese herbs including ginseng,Panax notoginseng,deer antlers,Carthamus tinctorius L.,Radix Paeoniae Alba,prepared Radix Rehmanniae,Angelica etc., which gains widespread application in the treatment of gynecological diseases. Based on the characteristics above, we try to explore its clinical application value in PCOS and its biological mechanisms.

Conditions
PCOS
Being tested
Dingkundan, Dingkundan & Diane-35, Diane-35
Keywords
PCOS, Dingkundan, Diane-35

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DingkundanDrug

    Also called A

    Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

  • Dingkundan & Diane-35Drug

    Also called A&B

    Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

  • Diane-35Drug

    Also called B

    Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

Study groups in NCT03264638
Study groupRoleWhat they receive
DingkundanExperimentalDingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
Receives: Drug: Dingkundan
Dingkundan & Diane-35ExperimentalDingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
Receives: Drug: Dingkundan & Diane-35
Diane-35Active comparatorDiane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
Receives: Drug: Diane-35

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. symptoms

    PCOS symptoms

    Measured: 5 minutes

  2. sex hormone levels changes

    sex hormone levels changes

    Measured: 5 minutes

Secondary outcomes (5)

  1. lipid metabolism

    blood lipid profile

    Measured: 5 minutes

  2. metabolites figure spectrum

    metabolites figure spectrum to undermine the mechanism of Dingkundan and Diane-35 in the treatment of PCOS

    Measured: 5 minutes

  3. Fasting insulin

    Fasting insulin

    Measured: 5 minutes

  4. glycosylated hemoglobin

    glycosylated hemoglobin

    Measured: 5 minutes

  5. fasting blood glucose

    fasting blood glucose

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start1 Oct 2016
  3. Primary completion31 Aug 2018 (estimated)
  4. Study completion31 Aug 2018 (estimated)

Resources

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
One third of participanta will receive Dingkun Dan Pills, one third of participanta will receive Diane-35 Pills, and the another third will receive Dingkun Dan pills and Diane-35 in combination.
Masking
None (open label)
Enrolment
315 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03264638
Sponsor's protocol ID
PCOS201708
Status last verified
Feb 2018
First submitted
13 Aug 2017
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Network platform, and the website will be attached later.

Publications

  • Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.

    PubMed 14688154

  • Amiri M, Ramezani Tehrani F, Nahidi F, Kabir A, Azizi F, Carmina E. Effects of oral contraceptives on metabolic profile in women with polycystic ovary syndrome: A meta-analysis comparing products containing cyproterone acetate with third generation progestins. Metabolism. 2017 Aug;73:22-35. doi: 10.1016/j.metabol.2017.05.001. Epub 2017 May 10.

    PubMed 28732568

  • Ding X, Deng Y, Wang Y, Xue W, Zhu S, Ma X, Ma R, Sun A. Serum metabolomic profiling reveals potential biomarkers in assessing the management of women with polycystic ovary syndrome: a randomized controlled trial. Chin Med J (Engl). 2022 Jan 5;135(1):79-85. doi: 10.1097/CM9.0000000000001705.

    PubMed 34873082

  • Deng Y, Wang YF, Zhu SY, Ma X, Xue W, Ma RL, Sun AJ. Is There An Advantage of Using Dingkun Pill () alone or in Combination with Diane-35 for Management of Polycystic Ovary Syndrome? A Randomized Controlled Trial. Chin J Integr Med. 2020 Dec;26(12):883-889. doi: 10.1007/s11655-020-3097-4. Epub 2020 Sep 11.

    PubMed 32915426

  • Deng Y, Xue W, Wang YF, Liu XH, Zhu SY, Ma X, Zuo HL, Jiang JF, Zheng TP, Sun AJ. Insulin Resistance in Polycystic Ovary Syndrome Improved by Chinese Medicine Dingkun Pill (): A Randomized Controlled Clinical Trial. Chin J Integr Med. 2019 Apr;25(4):246-251. doi: 10.1007/s11655-018-2947-1. Epub 2019 Jun 25.

    PubMed 31236888

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dingkundan, Dingkundan & Diane-35 and Diane-35 in people with PCOS, run by Aijun Sun 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 3 inclusion and 10 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 5 Feb 2018. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lei Li, MD (139-1198-8831 ext. +86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

symptoms (time frame: 5 minutes). 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 NCT03264638, which also lists 5 linked publications.

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 5 Feb 2018.

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