FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077095 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 26/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic adjunct therapy to AKT in pulmonary tuberculosis  
Scientific Title of Study   An open labelled exploratory clinical trial to evaluate the efficacy of Agastya Hareetaki Rasayana as adjunct to AKT in pulmonary tuberculosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhavi  
Designation  Assistant professor  
Affiliation  Muniyal Institute of Ayurveda Medical Sciences  
Address  Department of Kaychikitsa, 3rd floor, Muniyal Institute of Ayurveda Medical Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8792213330  
Fax    
Email  madhavirao551@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shripathi Acharya G 
Designation  Professor  
Affiliation  Muniyal Institute of Ayurveda Medical Sciences 
Address  Department of Kayachikitsa, 3rd floor, Muniyal Institute of Ayurveda Medical Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845387720  
Fax    
Email  shripathi_acharya@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Madhavi  
Designation  Assistant professor  
Affiliation  Muniyal Institute of Ayurveda Medical Sciences 
Address  Department of Kayachikitsa, 3rd floor, Muniyal Institute of Ayurveda Medical Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8792213330  
Fax    
Email  madhavirao551@gmail.com  
 
Source of Monetary or Material Support  
muniyal institute of ayurveda medical sciences, Shivalli Industrial Area, manipal, 576104 Karnataka, India  
 
Primary Sponsor  
Name  DrMadhavi 
Address  assistant professor department of kayachikitsa muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, 576104, karnataka, india  
Type of Sponsor  Other [SELF ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhavi  District Tuberculosis Center   Department-District Tuberculosis Center, Ground floor, Tuberculosis Division, District Hospital, Ajjarakad
Udupi
KARNATAKA 		 8792213330

madhavirao551@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
district TB Office   No Objection Certificate 
INSTITUTIONAL ETHICA COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:Z111||Encounter for screening for respiratory tuberculosis. Ayurveda Condition: KSHAYAJA-RAJAYAKSHMA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: AGASTYA HAREETAKI RASAYANA, Reference: ASHTANGA HRIDAYA , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: -JALA), Additional Information: -AS ADJUNCT TO AKT REGIMEN AS PER NTEP GUIDELINES
2Comparator Arm (Non Ayurveda)-AKT AKT Regimen for 2 months- initial phase
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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
• Subjects with complications like pleural effusion, fungal colonization of cavities
• Subjects diagnosed with uncontrolled Diabetes mellitus
• Pregnant or lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective parameters :
Physical and psychological domains of Quality of life (as per WHOQOL-100)
Objectives parameters: Will be assessed Before and After treatment
1) CBC, ESR, Urine analysis, LFT, CRP
2) X-ray chest PA view: Plain film radiograph to assess resolution of pathology
3) Sputum bacillary load
4) Weight
5) Serum Creatinine
6) Post prandial Blood glucose
7) Antituberculosis Immunoglobulin (quantitative analysis) 		 baseline,2nd,4th,6th,8th weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Signs and symptoms of shosha / rajayakshma/ kasa  0, 15, 30, 48 and 60th days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Tuberculosis (TB) is the most common cause of infectious disease–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 15–24-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.
 
Close