Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient

NCT02809027 | Completed Phase 4 DMC

• 1 other identifier: 114/59
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient.

Conditions

Post Cesarean Section Patient

Outcome Measures

Primary Outcomes (1)

• incidence abdominal distention as measured by diary chart (history taking and examination)

  72 hours

Secondary Outcomes (6)

• Maternal satisfaction as measured by questionaire

  72 hours

• Quality of life as measured by questionaire

  72 hours

• nausea vomiting as measured by questionaire

  72 hours

• first time to pass flatus/feces as measured by diary chart

  72 hours

• number of carminative drug use as measured by questionaire

  72 hours

Study Arms (2)

Ginger

ACTIVE COMPARATOR

Ginger capsule (500 mg), oral form, 2 capsules 3 time after meal for 3 days

Drug: Ginger

Placebo

SHAM COMPARATOR

Placebo capsule, oral form, 2 capsules 3 time after meal for 3 days

Drug: Placebo

Interventions

Ginger DRUG

Ginger

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Post cesarean section women

You may not qualify if:

• allergic to ginger
• time of cesarean section more than 1 hour
• perform another operation such as appendectomy, cystectomy
• former use carminative drugs
• already have abdominal distention

Sponsors & Collaborators

• Chulalongkorn University: lead

Related Publications (6)

• Carroll J, Alavi K. Pathogenesis and management of postoperative ileus. Clin Colon Rectal Surg. 2009 Feb;22(1):47-50. doi: 10.1055/s-0029-1202886.

  PMID: 20119556 BACKGROUND

• Chaiyakunapruk N, Kitikannakorn N, Nathisuwan S, Leeprakobboon K, Leelasettagool C. The efficacy of ginger for the prevention of postoperative nausea and vomiting: a meta-analysis. Am J Obstet Gynecol. 2006 Jan;194(1):95-9. doi: 10.1016/j.ajog.2005.06.046.

  PMID: 16389016 BACKGROUND

• O'Hara M, Kiefer D, Farrell K, Kemper K. A review of 12 commonly used medicinal herbs. Arch Fam Med. 1998 Nov-Dec;7(6):523-36. doi: 10.1001/archfami.7.6.523.

  PMID: 9821826 BACKGROUND

• Ushiroyama T, Sakuma K, Souen H, Nakai G, Morishima S, Yamashita Y, Kamegai H. Xiong-gui-tiao-xue-yin (Kyuki-chouketsu-in), a traditional herbal medicine, stimulates lactation with increase in secretion of prolactin but not oxytocin in the postpartum period. Am J Chin Med. 2007;35(2):195-202. doi: 10.1142/S0192415X07004734.

  PMID: 17436360 BACKGROUND

• Gibstein A, Cooper JJ, Wisot AL, Rosenthal AH. Prevention of postoperative abdominal distention and discomfort with simethicone. Obstet Gynecol. 1971 Sep;38(3):386-90. No abstract available.

  PMID: 4937581 RESULT

• Hu ML, Rayner CK, Wu KL, Chuah SK, Tai WC, Chou YP, Chiu YC, Chiu KW, Hu TH. Effect of ginger on gastric motility and symptoms of functional dyspepsia. World J Gastroenterol. 2011 Jan 7;17(1):105-10. doi: 10.3748/wjg.v17.i1.105.

  PMID: 21218090 RESULT

MeSH Terms

Interventions

ginger extract

Study Officials

• Vorapong Phupong, M.D.

  Chulalongkorn University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Vorapong Phupong

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 15, 2020

Record last verified: 2020-07