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Evaluation of the Anti-Cholelithiasis Activity of Vinegar-Soaked Ficus carica Fruit in Adults: A Randomized Controlled Trial

Protocol summary

Study aim
This randomized controlled trial aims to evaluate the anti-cholelithiasis activity of vinegar-soaked Ficus carica fruit in adults diagnosed with cholelithiasis.
Design
Pragmatic, community based, parallel group, single blinded, randomised controlled trial. Total 50 patients will be enrolled. Patients who met our inclusion criteria will be randomised into two groups. Treatment group-A and control group-B
Settings and conduct
At Noreen Nishat Welfare Hospital ,Khanewal ,Pakistan (ref no: 1015) after approval for the study design granted by the Review Board and the Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants in the study will be included who will be adults aged 18 to 50 years diagnosed with cholelithiasis, confirmed by a radiologist pediatrician through ultrasound testing and of both genders. Excluison criteria: The exclusion criteria included individuals with major systemic diseases, prior gallbladder surgery, gallstone medications, or pregnancy and lactating mothers
Intervention groups
Participants in the the control group-A will be given ursodiol 600 mg per day as the standard drug, and treatment group-B participants will be given VSFCF orally at a standard dose of 1g/kg/day for 3 months to assess the treatment’s effects. Both groups will be adhere to the same schedule and duration of administration for a comparative analysis of outcomes.
Main outcome variables
In the study, the primary outcome focus will be on evaluating changes in gallstone size that will be measured at the beginning and after 3 months of intervention. Additionally, secondary outcomes included analyzing the composition of gallstones to understand any structural changes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N7
Registration date: 2024-06-13, 1403/03/24
Registration timing: registered_while_recruiting

Last update: 2024-06-13, 1403/03/24
Update count: 0
Registration date
2024-06-13, 1403/03/24
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Anti-Cholelithiasis Activity of Vinegar-Soaked Ficus carica Fruit in Adults: A Randomized Controlled Trial
Public title
Anti-Cholelithiasis Activity of Vinegar-Soaked Ficus carica Fruit in Adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants in the study were adults aged 18 to 50 years Both male and female Participants diagnosed with cholelithiasis
Exclusion criteria:
Individuals with major systemic diseases Individuals with prior gallbladder surgery Individuals taking gallstone medications Pregnancy ladies Lactating mothers
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In the study, eligible adults will be randomly allocated to therapeutic groups at a 1 : 1 ratio using the permuted randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded study. Statistical analyser will be kept blind so that the result obtained will be without biasness
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
HBL Street near Sabsazar Metro Station
City
Multan
Postal code
66000
Approval date
2024-03-15, 1402/12/25
Ethics committee reference number
MIMAS/05/IAK Durrani

Health conditions studied

1

Description of health condition studied
Cholelithiasis
ICD-10 code
K80
ICD-10 code description
Cholelithiasis

Primary outcomes

1

Description
Evaluating changes in gallstone size
Timepoint
3 months
Method of measurement
Ultrasound or imaging techniques

Secondary outcomes

1

Description
Analyzing the composition of gallstones to understand any structural changes, assessing symptoms related to gallstones such as pain, bloating, and digestive discomfort to gauge symptomatic improvement, and monitoring safety parameters like adverse events
Timepoint
3 months
Method of measurement
By finding cholesterol, bilirubin, and calcium values in body and by liver function tests

Intervention groups

1

Description
Control group-A: The participants of control group-A will be given ursodiol 600 mg per day as the standard drug, ensuring that any observed results in the treatment group are due to the intervention itself rather than the effects of ursodiol.
Category
Treatment - Drugs

2

Description
Intervention group-B: Participants of treatment group-B will be given vinegar-soaked Ficus carica fruit (VSFCF) orally at a standard dose of 1g/kg/day for 3 months to assess the treatment’s effects.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Noreen Nishat Welfare Hospital, Khanewal, Pakistan
Full name of responsible person
Mashhud-Ul-Hasan Abid
Street address
Khanewal
City
Khanewal
Postal code
58150
Phone
+92 301 7412473
Email
mashhud.biochemist@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan
Full name of responsible person
Mashhud-Ul-Hasan Abid
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Postal code
66000
Phone
+92 301 7412473
Email
mashhud.biochemist@gmail.com
Grant name
Student fund
Grant code / Reference number
MIMAS/06/05/Malaika
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Muhammad Institute of Medical and Allied Sciences Multan
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Mashhud-Ul-Hasan Abid
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 301 7412473
Email
mashhud.biochemist@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture, Multan, Pakistan
Full name of responsible person
Imran Ahmad Khan
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Old Shujabad road, Multan, Pakistan
City
multan
Province
punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Malaika Bukhari
Position
Final year student BS (hons.) Biochemistry
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 334 6427398
Email
bmalaika82@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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