Clinical trial NCT06157034: Prokinetic Effect of Selected Nutraceuticals
Official title: Prokinetic Effect of Selected Nutraceuticals on Management of Gastrointestinal Disturbances Among Pulmonary Tuberculosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Tuberculosis
Gastro-Intestinal Disorder
Lead sponsor: Allama Iqbal Open University Islamabad
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Phase1 - 200 population size will be divided into 4 treatment groups

Phase2

* The phase will check the impact of selected nutraceuticals on TB patients with dietary counseling and all collected data in Phase1 will be repeated at the end
* 3 selected nutraceuticals Zingiber officinale, Carum carvi, and Mentha spicata will be used against placebo and each placed in a separate group with 50 subjects for 3 months
* Before dispensing treatments, raw material will be processed and encapsulated in prescribed doses in 4 groups after breakfast and dinner T1-Placebo 100mg/d, T2-Zingiber Officinale powder (500mg 2x/d=1000mg/d), T3-Carum powder(1g 2x/d=2g/d), T4-Mentha oil(2% of oil1.5ml 2x/d=30mg/d)

Phase3

- The impact of withholding the intervention will be studied to observe any change in selected parameters
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: --GIT disturbances
timeFrame: "1 Month" at study commencement (Phase 1)
measure: GIT disturbances
timeFrame: Termination of Phase 2 (Intervention period) "3 Months"
measure: GIT disturbances
timeFrame: Termination of phase 3 (Washout period) "1 Month"
Secondary outcomes:
measure: Body Mass Index
timeFrame: "through study completion, an average of 9 months"
measure: A self-designed / pretested questionnaire
timeFrame: "through study completion, an average of 9 months"
measure: Acid-Fast Bacillus (sputum)
timeFrame: "through study completion, an average of 9 months"
measure: Chest X-ray (CXR)
timeFrame: "1 Day" at study commencement (Phase 1)
measure: Complete blood count (CBC)
timeFrame: "1 Day" at study commencement (Phase 1)
Other outcomes:
Locations:
city: Rahim Yar Khan
country: Pakistan
facility: Sheikh Zayed Medical / college
state: Punjab
Study officials:
affiliation: Sheikh Zaid Medical / college.Rahim Yar Khan.Pakistan
name: Asma Latif, PhD Scholar
role: PRINCIPAL_INVESTIGATOR
References: