Gastro-Intestinal Disorder, Pulmonary Tuberculosis
Conditions
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.
Interventions
OTHERPlacebo
Inert Material
DIETARY_SUPPLEMENTZingier officinale powder
The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.
DIETARY_SUPPLEMENTCarum carvi, L powder
The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.
DIETARY_SUPPLEMENTMentha spicata oil
Mentha spicata L will be extracted in the form of oil and will be encapsulated.
Sponsors
Allama Iqbal Open University Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| --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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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 |
| 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. |
Countries
Pakistan
Outcome results
None listed