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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Inert Material
The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.
The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.
Sheikh Zayed Medical / college
Rahim Yar Khan, Punjab Province, Pakistan
--GIT disturbances
GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1.
Time frame: "1 Month" at study commencement (Phase 1)
GIT disturbances
GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 2 after completion of three-month intervention.
Time frame: Termination of Phase 2 (Intervention period) "3 Months"
GIT disturbances
GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 3 which is wash out time.
Time frame: Termination of phase 3 (Washout period) "1 Month"
Body Mass Index
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.
Time frame: "through study completion, an average of 9 months"
A self-designed / pretested questionnaire
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.
Time frame: "through study completion, an average of 9 months"
Acid-Fast Bacillus (sputum)
sample will be taken at time of enrollment in study to make diagnosis of Tuberculosis
Time frame: "through study completion, an average of 9 months"
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Mentha spicata L will be extracted in the form of oil and will be encapsulated.
Chest X-ray (CXR)
Phase 1 in which subjects will be enrolled and their CXR will be taken as criteria for diagnosis of TB
Time frame: "1 Day" at study commencement (Phase 1)
Complete blood count (CBC)
Phase 1 in which subjects will be enrolled and their CBC will be taken as criteria for diagnosis of TB
Time frame: "1 Day" at study commencement (Phase 1)