Ayurvedic adjunct therapy to AKT in pulmonary tuberculosis

Phase 2/3

Not yet recruiting

Conditions: Encounter for screening for respiratory tuberculosis. Ayurveda Condition: KSHAYAJA-RAJAYAKSHMA,

Registration Number: CTRI/2024/11/077095

Lead Sponsor: DrMadhavi

Brief Summary: Tuberculosis (TB) is the most common cause of infectious diseaseâ€“related mortality worldwide.

It is a major public health problem associated with social stigma in many parts of the world. [1]

Efforts for TB control have progressed steadily over the years and considerable progress has been

made in terms of diagnostics, treatment regimens and coverage. [2] However, India in 2021

witnessed a 19% increase of notified TB patients from the previous year. The total number of TB

patients (new and relapse) notified during 2021 were 19,33,381 and 16,28,161 in 2020.

Additionally, the prevalence of MDR-TB and XDR-TB has always been a challenge. The

estimated number of MDR and XDR-TB cases put on treatment as per the global TB report 2021

was 4 per 100,000 and 1 per 100,000 population, respectively. [3]

The incidence of TB is highest in the 15â€“24-year age group in India. The incidence rates in men,

women, and children being 60%, 34%, and 6%, respectively. [4]

Apart from being a public health problem, TB poses an economic burden on the society. Poverty

is both a risk factor and a consequence of TB, and it disproportionately affects the households with

low socio-economic status. [5]

Multiple aspects of the disease condition make it essential for an alternative approach to be

evaluated in aiding to the existing principles of treatment. [5] The important facets being

nourishment, quality of life, hepatoprotection and immunomodulation.

Undernutrition and TB form a vicious cycle, where undernutrition predisposes an individual to

acquire TB, while TB could exacerbate undernutrition. Nutritional support to TB patients improves

weight gain, adherence to therapy, muscle strength, quality of life, and reduced mortality.

GIT manifestations, hepatotoxicity, ototoxicity, nephrotoxicity, skin rashes, fever, peripheral

neuritis are the common side effects of anti-TB drugs. [6] Many studies support hepatoprotective

activities of glycosides, flavonoids, triterpenes and phenolic group of compounds extracted from

plants. [6] These phytochemicals possess antioxidants and free radical scavenging properties which,

prevent excessive lipid peroxidation in liver, decrease catalase, superoxide dismutase and

glutathione. [7]

Agastya-hareetaki rasayana contains Hareetaki as the main ingredient. It has been well reported

for its anti-oxidant, anti-mutagenic, anti-carcinogenic, anti-ageing, anti-bacterial, anti-tubercular,

anti-viral, anti-fungal, anti-diabetic, cardio-protective, hepato-protective, anti-ulcer and wound

healing properties. [8]

This study thus has been contemplated to evaluate the efficacy of Agastya-hareetaki rasayana as

adjunct to AKT in pulmonary tuberculosis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1 Newly diagnosed cases of pulmonary tuberculosis 2 Category I, II, III who are not seriously ill.
(As per RNTCP guidelines) 3 Subjects who are ready to sign the informed consent form.

Exclusion Criteria

1.Subjects with Extra pulmonary tuberculosis, HIV with or without ART 2.Subjects of MDR/XDR tuberculosis 3.Subjects on Immunosuppressive agents 4.Subjects with serious concomitant illness like renal failure, malignancies, cardiac failure â€¢ Subjects with complications like pleural effusion, fungal colonization of cavities â€¢ Subjects diagnosed with uncontrolled Diabetes mellitus â€¢ Pregnant or lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) CBC, ESR, Urine analysis, LFT, CRP	baseline,2nd,4th,6th,8th weeks
2) X-ray chest PA view: Plain film radiograph to assess resolution of pathology	baseline,2nd,4th,6th,8th weeks
3) Sputum bacillary load	baseline,2nd,4th,6th,8th weeks
Subjective parameters :	baseline,2nd,4th,6th,8th weeks
Physical and psychological domains of Quality of life (as per WHOQOL-100)	baseline,2nd,4th,6th,8th weeks
Objectives parameters: Will be assessed Before and After treatment	baseline,2nd,4th,6th,8th weeks
4) Weight	baseline,2nd,4th,6th,8th weeks
5) Serum Creatinine	baseline,2nd,4th,6th,8th weeks
6) Post prandial Blood glucose	baseline,2nd,4th,6th,8th weeks
7) Antituberculosis Immunoglobulin (quantitative analysis)	baseline,2nd,4th,6th,8th weeks

Secondary Outcome Measures

Name	Time	Method
Signs and symptoms of shosha / rajayakshma/ kasa	0, 15, 30, 48 and 60th days

Trial Locations

Locations (1): District Tuberculosis Center
🇮🇳
Udupi, KARNATAKA, India
District Tuberculosis Center
🇮🇳Udupi, KARNATAKA, India
Dr Madhavi
Principal investigator
8792213330
madhavirao551@gmail.com