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| Name | Class |
|---|---|
| West China Second University Hospital | OTHER |
| Chongqing Medical University No.1 Affiliated Hospital | UNKNOWN |
| The Second Hospital of Hebei Medical University | OTHER |
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This study is a national multicenter prospective, randomized, controlled trial, which evaluates Zhenqi Buxue Oral Liquid,Progesterone Capsules and the addition of Zhenqi Buxue Oral Liquid to Progesterone Capsules in the treatment of menstrual disorders in adults women. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.
Menstrual disorders are one of the most common clinical symptoms in women. Since puberty, about 70% of women have experienced menstrual disorders, including early, delayed, shortened, prolonged, and more importantly oligomenorrhea, amenorrhea, and decreased menstrual flow.At present, the main method of western medicine for the treatment of menstrual disorders is hormone replacement therapy, but the incidence of adverse reactions is high, and the clinical effect is mediocre. Traditional Chinese medicine in my country mostly adopts holistic conditioning therapy for the treatment of irregular menstruation.
Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and lazy words caused by insufficient qi and blood.
This study will conduct a comprehensive and in-depth study on its treatment of mental and psychological stress and menstrual disorders with "oligomenorrhea, amenorrhea, amenorrhea and decreased menstrual flow" as the main manifestations. The molecular mechanism and clinical improvement, and the safety and adverse reactions of its use paln to be clarified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zhenqi Buxue Oral Liquid | Experimental | Zhenqi Buxue Oral Liquid, 10 ml each time, 2 times a day for 3 menstrual cycles, orally |
|
| Zhenqi Buxue Oral Liquid and Progesterone Capsules | Experimental | Zhenqi Buxue Oral Liquid was taken orally, 10 ml at a time, twice a day for 3 menstrual cycles + orally from the second half of menstrual cycle, Progesterone Capsules 200mg, once a day for 10 days for 3 menstrual cycles |
|
| Progesterone Capsules | Active Comparator | Progesterone Capsules 200mg, qd*10 days*3 menstrual cycles, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZhenQi BuXue KouFuYe | Drug | Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and lazy words caused by insufficient qi and blood. |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual improvement | Menstrual improvement in cycle period | Within 3 months after the trial complete |
| Menstrual improvement | Menstrual improvement in menstrual volume | Within 3 months after the trial complete |
| Menstrual improvement | Menstrual improvement in number of days with bleeding or spotting | Within 3 months after the trial complete |
| Menstrual improvement | Menstrual improvement in monthly rates of amenorrhea | Within 3 months after the trial complete |
| Measure | Description | Time Frame |
|---|---|---|
| Sex hormone levels | mainly FSH, LH,E2 and AMH | Within 3 months after the trial complete |
| AFC | Changes in AFC in pelvic ultrasonography |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 10000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 20, 2022 | Mar 20, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Second Affiliated Hospital of Nanchang University |
| OTHER |
| Zhongda Hospital | OTHER |
| Maternal and Child Health Hospital of Hubei Province | OTHER |
| Liuzhou Maternity and Child Healthcare Hospital | OTHER |
| Zhejiang University Medical College Affiliated Hangzhou First People's Hospital | UNKNOWN |
| Guangzhou Women and Children's Medical Center | OTHER |
This study is a national multicenter prospective, randomized, controlled trial. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.
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| Progesterone Capsules | Drug | The main ingredient of Progesterone Capsules is abbsolutely progesterone,a kind of hormone,which is the main method of western medicine for the treatment of menstrual disorders |
|
| Within 3 months after the trial complete |
| SF-36 | The change of the MOS item short from health survey | Within 3 months after the trial complete |
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 1000730 | China |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |