Prokinetic Effect of Selected Nutraceuticals
- Conditions
- Pulmonary TuberculosisGastro-Intestinal Disorder
- Registration Number
- NCT06157034
- Lead Sponsor
- Allama Iqbal Open University Islamabad
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Newly diagnosed Pulmonary TB patients (both genders)
- Age group 18-65 years
- Symptoms criteria (Rome IV)
- Patients ˃ 18 years and ˂ 65 years.
- Patients registered with extra pulmonary disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method --GIT disturbances "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.
GIT disturbances 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 Outcome Measures
Name Time Method A self-designed / pretested questionnaire "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.
Complete blood count (CBC) "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
Body Mass Index "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.
Chest X-ray (CXR) "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
Acid-Fast Bacillus (sputum) "through study completion, an average of 9 months" sample will be taken at time of enrollment in study to make diagnosis of Tuberculosis
Trial Locations
- Locations (1)
Sheikh Zayed Medical / college
🇵🇰Rahim Yar Khan, Punjab, Pakistan
Sheikh Zayed Medical / college🇵🇰Rahim Yar Khan, Punjab, Pakistan