Prokinetic Effect of Selected Nutraceuticals

Prokinetic Effect of Selected Nutraceuticals on Management of Gastrointestinal Disturbances Among Pulmonary Tuberculosis Patients

Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural medicines help in alleviating gastrointestinal disturbances. This study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.

Study Overview

• Status: Completed
• Conditions: Pulmonary Tuberculosis; Gastro-Intestinal Disorder
• Intervention / Treatment: Other: Placebo; Dietary supplement: Zingier officinale powder; Dietary supplement: Carum carvi, L powder; Dietary supplement: Mentha spicata oil

Detailed Description

The aim of this study will be to evaluate if Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals can help in alleviating gastrointestinal disturbances in subjects which are more acceptable by the majority and have no side effects.

This Randomized Control interventional three arms Trial will comprise three phases. Patients will be randomized to Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals or placebo for three months. We will evaluate symptoms assessment, dietary assessment, biochemical and physical analysis i.e. Acid-Fast Bacillus (AFB) for sputum, Chest X-ray (CXR), and Complete Blood Count (CBC) at baseline and after 3 months since the study started.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rahim Yar Khan, Punjab, Pakistan, 64200
      • Sheikh Zayed Medical / college

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Newly diagnosed Pulmonary TB patients (both genders)
• Age group 18-65 years
• Symptoms criteria (Rome IV)

Exclusion Criteria:

• Patients ˃ 18 years and ˂ 65 years.
• Patients registered with extra pulmonary disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Exploratory; After sampling the study population of 200 will be divided into four (04) treatment groups i.e. T1 (Placebo), T2 (Zingiber officinale), T3 (Carum carvi, L), and T4 (Mentha spicata L).; Each group will be allotted 50 subjects
Experimental: T1; In the pursuit of scientific understanding, clinical studies play a pivotal role in evaluating the efficacy of treatments. One essential aspect is the inclusion of a placebo group, denoted as the T1 group in this study. Participants in this group will be administered inert material in the form of 100 mg capsules, serving as a baseline for comparison against the active treatment groups.; Group Designation: T1 Placebo GroupIntervention: 100 mg capsule containing inert materialDosage Frequency: DailyDuration: 3 monthsNumber of Participants: 50 subjects; Participants in the T1 Placebo Group are fully informed about the nature of the study, including the possibility of receiving a placebo.; Informed consent is obtained from each participant, ensuring that they are aware of the study's objectives and the potential for receiving an inactive treatment.	Other: Placebo; Inert Material
Experimental: T2; Zingiber officinale, commonly known as ginger, has been of interest for its potential health benefits.; In this clinical study, the T2 treatment group is designated to receive Zingiber officinale powder.; Intervention Details:Group Designation: T2 Treatment GroupIntervention: Zingiber officinale powderDosage: 500 mg capsulesDosage Frequency: Twice dailyTotal Daily Dosage: 1000 mgAdministration Timing: After breakfast and dinnerDuration: 3 months; Throughout the study duration, data will be systematically collected from participants in the T3 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.	Dietary supplement: Zingier officinale powder; The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.
Experimental: T3; Carum carvi, L, commonly known as caraway, is a botanical with a rich history of traditional use. In this clinical study, a treatment group, denoted as T3, is established to investigate the effects of encapsulated Carum carvi, L powder in alleviating the gastrointestinal disturbances among TB patients.; Intervention Details:Generic Name: Carum carvi, L powderDosage Form: EncapsulatedDosage: 1 g per capsuleFrequency: Twice dailyTotal Daily Dosage: 2 g/dayAdministration Timing: After breakfast and dinnerDuration of Treatment: 3 months; Throughout the study duration, data will be systematically collected from participants in the T3 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.	Dietary supplement: Carum carvi, L powder; The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.
Experimental: T4; Mentha spicata L, commonly known as spearmint, is renowned for its aromatic properties and potential health benefits. In this clinical study, a treatment group, designated as T4, is established to explore the effects of encapsulated Mentha spicata oil.; Intervention Details:Generic Name: Mentha spicata oilDosage Form: EncapsulatedConcentration: 2% of Spearmint essential oilDosage: 1.5 ml per capsuleFrequency: Twice dailyTotal Daily Dosage: 30 ml/dayAdministration Timing: After breakfast and dinnerDuration of Treatment: 3 months; Throughout the study duration, data will be systematically collected from participants in the T4 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.	Dietary supplement: Mentha spicata oil; Mentha spicata L will be extracted in the form of oil and will be encapsulated.
No Intervention: Washout period; In this phase impact of withholding the intervention on all parameters will be studied.; All parameters included in phase1 and 2 will be repeated after one month accordingly, to observe any change in selected parameters after discontinuation of intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
--GIT disturbances	GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1.	"1 Month" at study commencement (Phase 1)
GIT disturbances	GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 2 after completion of three-month intervention.	Termination of Phase 2 (Intervention period) "3 Months"
GIT disturbances	GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 3 which is wash out time.	Termination of phase 3 (Washout period) "1 Month"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg.	"through study completion, an average of 9 months"
A self-designed / pretested questionnaire	will be used to collect data on other determinants that affect patients regarding disease history, and dietary history. Agarwal Socio-economic status (SES) performa will be used.	"through study completion, an average of 9 months"
Acid-Fast Bacillus (sputum)	sample will be taken at time of enrollment in study to make diagnosis of Tuberculosis	"through study completion, an average of 9 months"
Chest X-ray (CXR)	Phase 1 in which subjects will be enrolled and their CXR will be taken as criteria for diagnosis of TB	"1 Day" at study commencement (Phase 1)
Complete blood count (CBC)	Phase 1 in which subjects will be enrolled and their CBC will be taken as criteria for diagnosis of TB	"1 Day" at study commencement (Phase 1)

Collaborators and Investigators

• Sponsor: Allama Iqbal Open University Islamabad
• Investigators: Principal Investigator: Asma Latif, PhD Scholar, Sheikh Zaid Medical / college.Rahim Yar Khan.Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Tuberculosis, Pulmonary
• Other Study ID Numbers: Allama Iqbal Open University.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No