NCT05757037

Brief Summary

The aim of the study to investigate effect of laser acupuncture on constipation predominant irritable bowel syndrome in female patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

February 24, 2023

Last Update Submit

January 14, 2024

Conditions

Constipation-predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

  • The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022)

    6 weeks

  • Irritable Bowel Syndrome Severity Score (IBS-SSS)

    6 weeks

Secondary Outcomes (2)

  • IBS Quality of Life (IBS-QOL) (Andrae et al., 2013)

    6 weeks

  • Visceral Sensitivity Index (VSI)

    6 weeks

Study Arms (2)

Laser acupuncture group

EXPERIMENTAL

The participants in this group will receive low level laser therapy 3 times weekly for 4 weeks. A diode laser emitter with a 650 nm wavelength, an average power of 30 mW, and a 0.15 cm2 spot size, with continuous wave, and exposure of 90 s per acupuncture point had been used in the current study at each of the following acupoints: : ST25, ST37 , LI11 , BL60 , and BL25 Also, participants will recieve received behavioral therapy advice: Sitting on the toilet for 10-15 min after breakfast and after dinner and maintaining the same bathroom schedule every day, sitting in the correct position on the toilet (leaning forward while resting forearms on thighs, raising both feet on a small block (like a step stool) with feet apart, relax and lower the shoulders, and do not suppress urges to defecate and relax stomach muscles). Dietary modifications include a high-fiber diet, fruits, vegetables, whole grain, dairy, and wheat

Device: laser acupuncture

Sham laser acupuncture

SHAM COMPARATOR

The participants in the control group will receive sham laser acupuncture treatment, without any laser output. The participants are unable to recognize whether they are being treated or not because laser acupuncture is a low-intensity and non-thermal laser irradiation. Also, participants will receive behavioral therapy advice.

Device: laser acupuncture

Interventions

laser acupunctureDEVICE

a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5W/cm2; pulsed wave; and Bahr frequencies \[B1: 599.5Hz, B2: 1199Hz, B3: 2398Hz, B4: 4776Hz, B5: 9552 Hz, B6: 19,104Hz, and B7: 38,208Hz\].

Laser acupuncture groupSham laser acupuncture

Eligibility Criteria

Age35 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants will meet diagnostic criteria (Rome IV) for IBS-C
  • Their age will range from 20-35 years old
  • Their body mass index (BMI) will range from \>18.5kg/m2 and \<29.9kg/m2

You may not qualify if:

  • Taking medications known to cause constipation
  • Any organic diseases that might induce constipation such as colorectal cancer, metabolic disorders, multiple sclerosis, or neurological disorders
  • Organic diseases of the small or large intestine such as ulcerative colitis and Crohn's disease
  • A history of gastrointestinal surgery (other than appendectomy or cholecystectomy)
  • Mechanical obstruction
  • Serious concomitant disease of the heart, liver, or kidney or diabetes
  • Pregnant or lactating women
  • Severe psychiatric disorders
  • Knowledgeable of acupoints and meridians that might unblind the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egypt , Giza

Giza, Egypt

RECRUITING

Central Study Contacts

sara Magdy Ahmed, lecturer

CONTACT

01063998331saramagdy87@cu.edu.eg

Marwa Shafik Mustafa Saleh, Ass.Prof

CONTACT

01008342466Marwa_shafiek2000@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PRINCIPAL INVESTIGATOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

March 1, 2023

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations

EG(1)