FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089191 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 16/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating the Impact of Ayurvedic Treatment as an Adjunct to Antituberculosis Therapy on BMI in Tuberculosis Patients. 
Scientific Title of Study   Efficacy Safety and Tolerability of Ayurveda regimen as an adjunct to antituberculosis treatment ATT and macronutrient supplementation on body weight nutritional outcomes and quality of life in adults with newly diagnosed drug sensitive smear positive Pulmonary Tuberculosis An open label randomized controlled parallel arm clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sonali Sarkar 
Designation  Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry 
Address  Department of Preventive and Social Medicine,JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9442174663  
Fax    
Email  sarkarsonaligh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonali Sarkar 
Designation  Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry 
Address  Department of Preventive and Social Medicine, JIPMER


PONDICHERRY
605006
India 
Phone  9442174663  
Fax    
Email  sarkarsonaligh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonali Sarkar 
Designation  Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry 
Address  Department of Preventive and Social Medicine, JIPMER


PONDICHERRY
605006
India 
Phone  9442174663  
Fax    
Email  sarkarsonaligh@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush. 61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058, India 
 
Primary Sponsor  
Name  Ministry of Ayush 
Address  Ministry of Ayush, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi – 110023 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
DEPARTMENT OF BIOTECHNOLOGY  6th-8th Floor, Block 2 and 4th-5th Floor, Block 3 CGO Complex, Lodhi Road New Delhi - 110 003.India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Himashree Bhattacharyya  AIIMS GUWAHATI  Dept. of Community & family Medicine, AIIMS Guwahati, Silbharal Changsari, Guwahati, Assam 781101
Kamrup
ASSAM 		 94369-85886

himashreebhattacharyya@gmail.com 
Dr Pankaja Ravi Raghav  AIIMS JODHPUR  C-201, Medical College Building, AIIMS, Jodhpur, Basni Phase 2nd (Rajasthan) – 342 005
Jodhpur
RAJASTHAN 		 8003996904

raghavpankaja3@gmail.com 
Dr Yogesh Bahurupi  AIIMS NAGPUR  4th Floor, Medical College Building AIIMS Nagpur Campus, Plot no. 2, Sector -20, MIHAN, Nagpur, 441108
Nagpur
MAHARASHTRA 		 9655007473

dr.yogeshab@gmail.com 
Dr Rakesh Kumar  AIIMS NEW DELHI  Room No-27 Centre for Community Medicine Old OT Block, Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI 		 01126593761

rakeshkumar@aiims.edu 
Dr Bijaya Nanda Naik  AIIMS PATNA  Department of CFM, Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507
Patna
BIHAR 		 8870763201

drbijaya@aiimspatna.org 
Dr Sindhu Joshi  BHAGWAN MAHAVIR MEDICAL RESEARCH CENTRE HYDERABAD  Bhagavan Mahavir Medical Research Centre, Plot No 10-1-1, Bhagwan Mahavir Marg, AC Guards, Hy-derabad 500004 Telangana
Hyderabad
TELANGANA 		 9391099991

dr_sindhu@yahoo.com 
Dr Sonali Sarkar  JIPMER  3rd Floor, JIPMER International School of Public Health, JIPMER Campus, Puducherry, 605006
Pondicherry
PONDICHERRY 		 9442174663

sarkarsonaligh@gmail.com 
Dr W Valarie Lyngdoh  NORTH EASTERN INDIRA GANDHI REGIONAL INSTITUTE OF HEALTH AND MEDICAL SCIENCES SHILLONG  Department of Microbiology, NEIGRIHMS, Mawdiangdiang, Shillong-793018
East Khasi Hills
MEGHALAYA 		 9862079610

drvalarielyngdoh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE -INTERVENTION STUDIES JIPMER, Puducherry  Approved 
INSTITUTIONAL ETHICS COMMITTEE AIIMS Guwahati  Approved 
INSTITUTIONAL ETHICS COMMITTEE AIIMS Patna  Approved 
INSTITUTIONAL ETHICS COMMITTEE AIIMS, New Delhi  Approved 
INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL RESEARCH BMMRC, Hyderabad  Approved 
INSTITUTIONAL ETHICS COMMITTEE FOR CLINICAL TRIAL AIIMS Nagpur  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE NEIGRIHMS, Shillong  Approved 
INSTITUTIONAL HUMAN ETHICS COMMITTEE (CLINICAL TRIAL) AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:A150||Tuberculosis of lung. Ayurveda Condition: RAJAYAKSHMA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Group II (Control group)The existing daily fixed-dose ATT regimen for six months along with macronutrient supplementation*.*Food basket containing approximately 1200 kcal of energy and 52 g proteins/day (based on the ICMR funded RATIONS study)
2Intervention ArmDrugClassical(1) Medicine Name: Cap Shunthi (Zingiber officinale) , Reference: (Ayurvedic Pharmacopoeia of India (API), Part I, Vol I, Pg No.103-104, First Edition),, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: With lukewarm water), Additional Information: Dosage: Two capsules of 500 mg each twice daily 30 minutes before meals with lukewarm water
(2) Medicine Name: Tab Ashwagandha (Withania somnifera aqueous extract) , Reference: (Ayurvedic Pharmacopoeia of India (API), Part I, Vol I, Pg No.15-16, First Edition) , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 170 Days, anupAna/sahapAna: Yes(details: With lukewarm water), Additional Information: Dosage:Two tablets of 500 mg each twice daily one hour after meals with lukewarm water: Duration:From 8th day till six months duration of ATT
(3) Medicine Name: Drakshavleha , Reference: (Ayurvedic Pharmacopoeia of India (API), Part II, Vol II, First Edition, Pg No. 71-73), Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 170 Days, anupAna/sahapAna: Yes(details: With lukewarm water), Additional Information: Dosage:10 gm twice daily one hour after meals with lukewarm water; Duration:From 8th day till six months duration of ATT
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Willing and able to give informed consent for participation in the trial.

2.Individuals of any gender aged 18 years or above.

3.Newly diagnosed cases of Pulmonary Tuberculosis (M. Tb positive on molecular test e.g. GeneXpert or TRUENAT or sputum smear positive pulmonary TB on direct microscopy for acid fast bacilli (at least 1+ on the IUATLD/WHO scale)

4.Sensitive to rifampicin by sputum based drug sensitivity test (may be sensitive or resistant to isoniazid)

5.Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.

6.Liver function tests within reference range (as per the reference value of the laboratory assigned for the study investigations)
 
 
ExclusionCriteria 
Details  1.Patients with prehistory of TB, EP, relapse, and other forms of TB

2.Participants with pre-existing HIV, liver, Kidney and cardiac diseases

3.Hb<7 gm/dl and HbA1C > 10%

4.Pregnancy and lactation, Hypersensitivity to ATT



 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•Change in body mass index (BMI) from baseline to day 180   Time points- Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 
 
Secondary Outcome  
Outcome  TimePoints 
•Change in body weight from baseline to day 180   Time points- Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 
• Change in body composition from baseline to day 180, assessed through Dual Energy X-ray Absorptiometry (DEXA)  Time points- Baseline, Day 180 
• Change in health-related quality-of-life (HRQoL) in pulmonary tuberculosis from baseline to day 180, assessed through SF-12 questionnaire   Time points- Baseline, Day 90, Day 180 
•Time to attain sputum smear negative for AFB   Time points- Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 
•Proportion of participants who attain sputum smear negative for AFB at each follow-up time points (  Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180) and culture conversion to negative status through MGIT (Mycobacteria Growth Indicator Tube)(Time points - Baseline, Day 180) 
• Quantitative assessment of mycobacterial load through quantitative polymerase chain reaction (qPCR for Mycobacterium tuberculosis)  Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 
•Incidence of treatment emergent adverse events   Baseline to Day 180 
•Change in laboratory parameters of safety (CBC, LFT, KFT)   Baseline, Day 30, Day 90, Day 180 
• To assess the tolerability of Ayurvedic therapeutic regimen as adjunct to ATT and macronutrient supplementation in Pulmonary tuberculosis (through assessment of treatment adherence, proportion of participants dropped out or withdrawn from the study due to AE/ADR and participant self reported tolerability)   Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 
 
Target Sample Size   Total Sample Size="1250"
Sample Size from India="1250" 
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 3/ Phase 4 
Date of First Enrollment (India)   04/08/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sarkarsonaligh@gmail.com].

  6. For how long will this data be available start date provided 28-01-2033 and end date provided 01-01-2038?
    Response (Others) -  Data will be available to the public after 7 years of study completion

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The current treatment for drug-susceptible TB (DS-TB) involves a combination of four antibiotics: isoniazid (INH), rifampicin (RIF), pyrazinamide (PZA), and ethambutol (EMB), which target Mycobacterium tuberculosis via different mechanisms. Despite effectiveness, adverse effects like liver dysfunction and drug resistance are concerns. Limited new drug approvals since 2013 highlight the need for more efficient anti-TB drugs. Additionally, the emergence of drug-resistant strains poses a substantial risk to successful treatment outcomes. Given these challenges, there is a critical need for novel adjunct therapeutic strategies to address drug resistance, minimize toxicity, and enhance patient outcomes.

 
Close