Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture and/or Diclectin Treatment for Nausea and Vomiting of Pregnancy (NVPAct)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401384
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : July 30, 2020
Sponsor:
Collaborators:
Heilongjiang maternal and child health care hospital
Harbin maternal and child health care hospital
Mudanjiang maternal and child health care hospital
Jixi maternal and child health care hospital
Qitaihe maternal and child health care hospital
Shuangyashan maternal and child health care hospital
Jiamusi maternal and child health care hospital
Hegang maternal and child health care hospital
Yichun maternal and child health care hospital
Suihua maternal and child health care hospital
Heilongjiang provincial hospital
First affiliated hospital, Heilongjiang university of Chineses medicine
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine

Brief Summary:

Nausea and vomiting in pregnancy (NVP) is one of the most common symptoms of pregnancy affecting 50-85% of women during the first half of pregnancy. Maternal morbidity is common and includes psychological effects, financial burden, clinical complications from nutritional deficiencies, gastrointestinal trauma, and in rare cases, neurological damage. As the main means of alternative treatment, economical and easy to obtain; the clinical efficacy of acupuncture treatment of this disease has low level of evidence and needs to be reconfirmed. Doxylamine vitamin B6 sustained release tablets (Diclectin, combination of doxylamine succinate (10mg) and pyridoxine hydrochloride (10mg) are The American College of Obstetricians and Gynecologists recommends with Level A evidence the use of vitamin B6 in combination with doxylamine as first-line pharmacotherapy for treatment of NVP. The efficacy and safety of Diclectin has been confirmed in many years of research, but there is no evidence of high-level evidence-based medicine for the Chinese population. The purpose of this multicenter, randomized, double-blind, placebo-controlled trial was to investigate the efficacy and safety of acupuncture versus Diclectin in the treatment of NVP.

We hypothesis that: (1)Active acupuncture plus Diclectin (Arm A) or sham acupuncture combined with Diclectin (Arm B) or active acupuncture plus Diclectin placebo (Arm C) is more effective than the sham acupuncture plus Diclectin placebo (Arm D). (2)Sham acupuncture combined with Diclectin (Arm B) and active acupuncture plus Diclectin placebo (Arm C) will have similar treatment effects. (3)Active acupuncture plus Diclectin (Arm A) is no more effective than sham acupuncture combined with Diclectin (Arm B) and active acupuncture plus Diclectin placebo (Arm C).


Condition or disease Intervention/treatment Phase
Nausea and Vomiting of Pregnancy Other: Diclectin and acupuncture Not Applicable

Detailed Description:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Subjects will be randomized into one of the four treatment arms: 1) Diclectin+ active acupuncture; 2) Diclectin+ sham acupuncture; 3) Diclectin Placebo+ active acupuncture; 4) Diclectin Placebo+ sham acupuncture.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture and/or Diclectin Treatment for Nausea and Vomiting of Pregnancy : A Two by Two Factorial Trial (NVPAct)
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Diclectin and acupuncture
1) Diclectin + active acupuncture; 2) Diclectin + sham acupuncture; 3) Diclectin Placebo + active acupuncture; 4) Diclectin Placebo + sham acupuncture

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.
Other: Diclectin and acupuncture
1) Diclectin + active acupuncture; 2) Diclectin + sham acupuncture; 3) Diclectin Placebo + active acupuncture; 4) Diclectin Placebo + sham acupuncture

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.
Other: Diclectin and acupuncture
1) Diclectin + active acupuncture; 2) Diclectin + sham acupuncture; 3) Diclectin Placebo + active acupuncture; 4) Diclectin Placebo + sham acupuncture

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.
Other: Diclectin and acupuncture
1) Diclectin + active acupuncture; 2) Diclectin + sham acupuncture; 3) Diclectin Placebo + active acupuncture; 4) Diclectin Placebo + sham acupuncture




Primary Outcome Measures :
  1. Change from baseline Pregnancy-Unique Quantification of Emesis and Nausea scores at 14 days treatment [ Time Frame: Through study completion, an average of 14 days ]
    Mean difference in Pregnancy-Unique Quantification of Emesis and Nausea scores after 14 days treatments


Secondary Outcome Measures :
  1. Change from baseline in Global assessment of well-being [ Time Frame: Through study completion, an average of 14 days ]
    Mean difference in Global assessment of well-being after 14 days treatments

  2. The day-by-day area under the curve for change in Pregnancy-Unique Quantification of Emesis and Nausea scores [ Time Frame: Through study completion, an average of 14 days ]
    The day-by-day area under the curve for change in Pregnancy-Unique Quantification of Emesis and Nausea scores from baseline

  3. Side effects [ Time Frame: Through study completion, an average of 14 days ]
    Cumulative side effects during the treatment period

  4. Study withdraw [ Time Frame: Through study completion, an average of 14 days ]
    Rate of study withdraw

  5. Concurrent treatment [ Time Frame: Through study completion, an average of 14 days ]
    The proportion of concurrent treatment

  6. Time loss from employment [ Time Frame: Through study completion, an average of 14 days ]
    Cumulative time loss from employment

  7. The amount of Diclectin that women will continue use during one month follow-up [ Time Frame: Through follow-up period, an average of 28 days ]
    The amount of Diclectin in each arm where women will continue use of site package medication during one month follow-up if symptoms persist.

  8. Change from baseline quality of life scores of nausea and vomiting in pregnancy after 14 days treatments [ Time Frame: Through study completion, an average of 14 days ]
    Mean difference in quality of life scores of nausea and vomiting in pregnancy after 14 days treatments

  9. Change from baseline Visual analog scale after 14 days treatments [ Time Frame: Through study completion, an average of 14 days ]
    Mean difference in visual analog scale after 14 days treatments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401384


Contacts
Layout table for location contacts
Contact: Xiaoke Wu, Ph.D 13796025599 xiaokewu2002@vip.sina.com

Locations
Layout table for location information
China, Heilongjiang
First Affiliated Hospital, Heilongjiang University of Chinese Medicine Recruiting
Harbin, Heilongjiang, China, 150040
Contact: Xinming Yang         
Principal Investigator: Xinming Yang         
Mudanjiang maternal and children hospital Recruiting
Mudanjiang, Heilongjiang, China
Contact: Yingmei Cui         
Principal Investigator: Yingmei Cui         
Sponsors and Collaborators
Xiaoke Wu
Heilongjiang maternal and child health care hospital
Harbin maternal and child health care hospital
Mudanjiang maternal and child health care hospital
Jixi maternal and child health care hospital
Qitaihe maternal and child health care hospital
Shuangyashan maternal and child health care hospital
Jiamusi maternal and child health care hospital
Hegang maternal and child health care hospital
Yichun maternal and child health care hospital
Suihua maternal and child health care hospital
Heilongjiang provincial hospital
First affiliated hospital, Heilongjiang university of Chineses medicine
Investigators
Layout table for investigator information
Study Chair: Xiaoke Wu, Ph.D First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Layout table for additonal information
Responsible Party: Xiaoke Wu, Director of Obstetrics and Gynecology Department, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT04401384    
Other Study ID Numbers: NVPAct
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Xiaoke Wu, Heilongjiang University of Chinese Medicine:
Nausea and Vomiting of Pregnancy
PUQE
Acupuncture
Diclectin
Additional relevant MeSH terms:
Layout table for MeSH terms
Pregnancy Complications
Nausea
Vomiting
Signs and Symptoms, Digestive
Dicyclomine, doxylamine, pyridoxine drug combination
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action