NCT06157034

Prokinetic Effect of Selected Nutraceuticals

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Allama Iqbal Open University Islamabad · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis
• Gastro-Intestinal Disorder

Interventions

Type	Name	Description
OTHER	Placebo	Inert Material
DIETARY_SUPPLEMENT	Zingier officinale powder	The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.
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.
DIETARY_SUPPLEMENT	Mentha spicata oil	Mentha spicata L will be extracted in the form of oil and will be encapsulated.

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-02-15
• Completion: 2022-03-15
• First posted: 2023-12-05
• Last updated: 2023-12-05

Locations

1 site across 1 country: Pakistan