Acupuncture and/or Diclectin Treatment for Nausea and Vomiting of Pregnancy
Palavras-chave
Resumo
Descrição
Subjects will be randomized into one of the four treatment arms: A) Diclectin (combination of doxylamine succinate and pyridoxine hydrochloride, 2 tablets/day at bedtime) + active acupuncture(30min once every other day); B) Diclectin (2 tablets/day at bedtime) + sham acupuncture (30min once every other day); C) Diclectin Placebo (2 tablets/day at bedtime) + active acupuncture(30min once every other day); D) Diclectin Placebo (2 tablets/day at bedtime) + sham acupuncture (30min once every other day). Participants will receive active acupuncture or sham acupuncture treatment every other day (or once every day if the symptoms are unrelieved (PUQE≧6)) for 2 consecutive weeks, 7-14 times in total, and receive Diclectin or placebo treatment every day (2 tablets at bedtime for the first day, if the symptoms are unrelieved (PUQE≧6), add one tablet in the morning, if the symptoms are still unrelieved (PUQE≧6), add another one tablet at three o 'clock in the afternoon) for 2 consecutive weeks, 28-56 tablets in total. Daily measurement PUQE score, Visual analog scale (VAS) and AEs. Weekly visits will include global assessment of well-being, adverse events and concomitant medications, and a patient diary. The visit after treatment will assess NVP quality of life (NVPQoL), SAS and SDS, and primary and secondary outcomes. Participants will be followed up by telephone 30 days after treatment.
Primary outcomes: PUQE scores.
Secondary outcomes:
(1)Change in Global assessment of well-being. (2)The day-by-day area under the curve for change in PUQE from baseline. (3)Adverse events. (4)Study withdraw. (5)The number of women in each group who reported concurrent use of other alternate therapy for NVP. (6)Time loss from employment. (7)The amount of Diclectin in each arm where women will continued with compassionate use of site package medication (OTC drug) during one-month follow-up if symptoms persist. (8)Reliability and validity analysis of PUQE, if it is associated with clinical outcomes that are related directly to NVP(such as a pregnant woman's ability to take multivitamins, rates of emergency room visits and hospitalization for NVP, health care costs for NVP, and a woman's self-reported scores of well-being in NVP). (9)Change in NVPQOL. (10)Change in Visual analog scale
datas
| Última verificação: | 04/30/2020 |
| Enviado pela primeira vez: | 05/17/2020 |
| Inscrição estimada enviada: | 05/19/2020 |
| Postado pela primeira vez: | 05/25/2020 |
| Última atualização enviada: | 05/19/2020 |
| Última atualização postada: | 05/25/2020 |
| Data real de início do estudo: | 05/31/2020 |
| Data Estimada de Conclusão Primária: | 12/30/2020 |
| Data Estimada de Conclusão do Estudo: | 06/29/2021 |
Condição ou doença
Intervenção / tratamento
Other: Diclectin and acupuncture
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Diclectin and active acupuncture Diclectin (combination of doxylamine succinate and pyridoxine hydrochloride, 2 tablets/day at bedtime) + active acupuncture(30min once every other day). Participants will receive active acupuncture or sham acupuncture treatment every other day (or once every day if the symptoms are unrelieved (PUQE≧6)) for 2 consecutive weeks, 7-14 times in total, and receive Diclectin or placebo treatment every day (2 tablets at bedtime for the first day, if the symptoms are unrelieved (PUQE≧6), add one tablet in the morning, if the symptoms are still unrelieved (PUQE≧6), add another one tablet at three o 'clock in the afternoon) for 2 consecutive weeks, 28-56 tablets in total. | |
| Placebo Comparator: Diclectin and sham acupuncture Diclectin (2 tablets/day at bedtime) + sham acupuncture (30min once every other day); Participants will receive active acupuncture or sham acupuncture treatment every other day (or once every day if the symptoms are unrelieved (PUQE≧6)) for 2 consecutive weeks, 7-14 times in total, and receive Diclectin or placebo treatment every day (2 tablets at bedtime for the first day, if the symptoms are unrelieved (PUQE≧6), add one tablet in the morning, if the symptoms are still unrelieved (PUQE≧6), add another one tablet at three o 'clock in the afternoon) for 2 consecutive weeks, 28-56 tablets in total. | |
| Placebo Comparator: Diclectin Placebo and active acupuncture Diclectin Placebo (2 tablets/day at bedtime) + active acupuncture(30min once every other day). Participants will receive active acupuncture or sham acupuncture treatment every other day (or once every day if the symptoms are unrelieved (PUQE≧6)) for 2 consecutive weeks, 7-14 times in total, and receive Diclectin or placebo treatment every day (2 tablets at bedtime for the first day, if the symptoms are unrelieved (PUQE≧6), add one tablet in the morning, if the symptoms are still unrelieved (PUQE≧6), add another one tablet at three o 'clock in the afternoon) for 2 consecutive weeks, 28-56 tablets in total. | |
| Placebo Comparator: Diclectin Placebo and sham acupuncture Diclectin Placebo (2 tablets/day at bedtime) + sham acupuncture (30min once every other day). Participants will receive active acupuncture or sham acupuncture treatment every other day (or once every day if the symptoms are unrelieved (PUQE≧6)) for 2 consecutive weeks, 7-14 times in total, and receive Diclectin or placebo treatment every day (2 tablets at bedtime for the first day, if the symptoms are unrelieved (PUQE≧6), add one tablet in the morning, if the symptoms are still unrelieved (PUQE≧6), add another one tablet at three o 'clock in the afternoon) for 2 consecutive weeks, 28-56 tablets in total. |
Critério de eleição
| Idades qualificadas para estudar | 20 Years Para 20 Years |
| Sexos elegíveis para estudo | Female |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: 1. Women ≥20 to ≤45 years of age 2. 7-14 week gestations /49-98 days after the first day of their last menstrual period(LMP) 3. NVP in pregnancy with PUQE score ≥6 4. Within 20% of normal weight at the beginning of pregnancy diagnosis 5. Viable single intrauterine pregnancy by pelvic ultrasound 6. Giving written consent Exclusion Criteria: 1. Having major medical problems such as malignant tumor, acute or subacute severe hepatitis, severe aplastic anemia, ITP, acute appendicitis, acute pancreatitis, TORCH syndrome, etc. 2. Having chronic medical conditions such as poorly controlled diabetes, Coronary heart disease (CHD), uncontrolled hypertension, etc. 3. Coexistence of other disease that cause vomiting such as thyroid disease, gastrointestinal disease, infections disease, gestational trophoblastic disease(GTD), etc. 4. Having asthma, increased intraocular pressure, narrow-angle glaucoma, narrow peptic ulcer, pyloric obstruction, and bladder neck obstruction, etc. 5. Taking medications such as antiemetic such as Vitamin B6, Ondansetron, Metoclopramide, Prednisone, etc. 6. Having response to conservative Rx (dietary and lifestyle modification) 7. Abnormal physical examination and laboratory tests(Minor abnormalities in laboratory tests due to pregnancy vomiting, such as liver function and ions are excluded). 8. Mentally handicapped and psychological disorders. 9. Hypersensitivity to the doxiramine, other ethanolamine-derived antihistamines, pyridoxine hydrochloride, and any inactive ingredient in Diclectin. 10. Using monoamine oxidase (MAO) inhibitors. 11. Driving or operating heavy machinery. 12. Using alcohol or other central nervous system (CNS) inhibitors such as Diazepam, phenobarbital, etc. |
Resultado
Medidas de Resultado Primário
1. Change from baseline Pregnancy-Unique Quantification of Emesis and Nausea scores at 14 days treatment [Through study completion, an average of 14 days]
Medidas de Resultado Secundário
1. Change from baseline in Global assessment of well-being [Through study completion, an average of 14 days]
2. The day-by-day area under the curve for change in Pregnancy-Unique Quantification of Emesis and Nausea scores [Through study completion, an average of 14 days]
3. Side effects [Through study completion, an average of 14 days]
4. Study withdraw [Through study completion, an average of 14 days]
5. Concurrent treatment [Through study completion, an average of 14 days]
6. Time loss from employment [Through study completion, an average of 14 days]
7. The amount of Diclectin that women will continue use during one month follow-up [Through follow-up period, an average of 28 days]
8. Change from baseline quality of life scores of nausea and vomiting in pregnancy after 14 days treatments [Through study completion, an average of 14 days]
9. Change from baseline Visual analog scale after 14 days treatments [Through study completion, an average of 14 days]
