The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation

NCT01185431 | Completed DMC

• 1 other identifier: CTCF2_2010_YM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is being conducted to look for following changes when fig paste is taken by female subjects with functional constipation: To evaluate the improvement of the bowel To assess the quality of life and impact on female reproductive function To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol

Conditions

Functional Constipation

Keywords

Ficus Carica; Functional Constipation; Dietary Supplement; Fig Paste

Outcome Measures

Primary Outcomes (1)

• Colonic transit time

  Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).

  116 day

Secondary Outcomes (3)

• Questionnaire for evacuation

  116 day

• Questionnaire for quality of life

  116 day

• Questionnaire for woman reproductive function

  116 day

Study Arms (2)

Ficus carica (Fig paste)

EXPERIMENTAL

Dietary Supplement: Ficus carica (Fig paste)

Control (Placebo paste)

PLACEBO COMPARATOR

Dietary Supplement: Placebo (Placebo paste)

Interventions

Ficus carica (Fig paste) DIETARY_SUPPLEMENT

Ficus carica paste 300g/day

Ficus carica (Fig paste)

Placebo (Placebo paste) DIETARY_SUPPLEMENT

Placebo composition 300g/day

Control (Placebo paste)

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who are female volunteers (unmarried), 19\~40 years
• Subject who have functional constipation by ROME IIII criteria
• Subject who have over 36 hour colonic transit time
• Subject must provide written informed consent to participate in the study

You may not qualify if:

• Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, Cardiovascular disease
• Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
• Subject with uterine fibroids at ultrasonography
• Subject is pregnant, planning to become pregnant, or breast-feeding
• Subjects with childbearing potential (i.e. pre-menopausal, not surgically sterile) not willing to use a medically accepted contraceptive (oral contraception) regimen
• Known history of moderate to severe hepatic impairment (i.e., serum ALT\>1.5×ULN, AST\>1.5×ULN)
• Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure ≤ 95 mmHg or diastolic blood pressure ≤ 60 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
• Subjects with significant hypersensitivity about Ficus carica
• Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration
• Subjects who participated in other clinical investigation within 2 months prior to first administration
• Subject who drink constantly (21 units/week over)
• Subject who have Irritable bowel syndrome by ROME IIII criteria
• Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study (i.e., laboratory test and others)

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

Study Officials

• Soo-Wan Chae, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 20, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

KR (1)