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Completed

NCT Number: NCT06157034

Prokinetic Effect of Selected Nutraceuticals

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.

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Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Gastro-Intestinal Disorder Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Medical / college

Rahim Yar Khan, Punjab Province, 64200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Inert Material

Zingier officinale powder

Dietary Supplement

The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.

Carum carvi, L powder

Dietary Supplement

The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.

Mentha spicata oil

Dietary Supplement

Mentha spicata L will be extracted in the form of oil and will be encapsulated.

Primary outcomes

  1. --GIT disturbances

    Time frame: "1 Month" at study commencement (Phase 1)

    GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1.

  2. GIT disturbances

    Time frame: Termination of Phase 2 (Intervention period) "3 Months"

    GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 2 after completion of three-month intervention.

  3. GIT disturbances

    Time frame: Termination of phase 3 (Washout period) "1 Month"

    GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 3 which is wash out time.

Secondary outcomes

  1. Body Mass Index

    Time frame: "through study completion, an average of 9 months"

    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.

  2. A self-designed / pretested questionnaire

    Time frame: "through study completion, an average of 9 months"

    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.

  3. Acid-Fast Bacillus (sputum)

    Time frame: "through study completion, an average of 9 months"

    sample will be taken at time of enrollment in study to make diagnosis of Tuberculosis

  4. Chest X-ray (CXR)

    Time frame: "1 Day" at study commencement (Phase 1)

    Phase 1 in which subjects will be enrolled and their CXR will be taken as criteria for diagnosis of TB

  5. Complete blood count (CBC)

    Time frame: "1 Day" at study commencement (Phase 1)

    Phase 1 in which subjects will be enrolled and their CBC will be taken as criteria for diagnosis of TB

Sponsors and collaborators

Lead sponsor

Allama Iqbal Open University Islamabad

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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