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CTRI Number  CTRI/2025/02/080608 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of draksharishta as a physical health promoter in treated cases of pulmonary tuberculosis 
Scientific Title of Study   A comparative clinical study to evaluate the effect of draksharishta as a physical health promoter in treated cases of rajayakshma vis-a-vis pulmonary tuberculosis  
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 Shivani Parganiha  
Designation  PG Scholar  
Affiliation  JSS Ayurveda medical college and hospital 
Address  Department of PG Studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9479053639  
Fax    
Email  shivani31par@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini S 
Designation  Reader 
Affiliation  JSS Ayurveda medical college and hospital 
Address  Department of PG Studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9886600552  
Fax    
Email  shalini6771@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shalini S 
Designation  Reader 
Affiliation  JSS Ayurveda medical college and hospital 
Address  Department of PG Studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru


KARNATAKA
570028
India 
Phone  9886600552  
Fax    
Email  shalini6771@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda medical college and hospital, Lalithadripura Road, Mysuru, India 570028 
PK TB and CD Hospital, Kumbarakoppal, Gokulam, Mysuru, India 570016 
 
Primary Sponsor  
Name  Dr Shivani Parganiha 
Address  Department of PG Studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru  
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 Shivani Parganiha  JSS Ayurveda medical college and hospital  Department of PG studies in Swasthavritta, OPD 12, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru
Mysore
KARNATAKA 
9479053639

shivani31par@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Ayurveda medical college  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
1Intervention ArmDrugClassical(1) Medicine Name: Draksharishta, Reference: Bhaishajya Kalpana, Route: Oral, Dosage Form: Arishta, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: -
2Comparator Arm (Non Ayurveda)-Wait list group
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Subjects between the age of 18-45 years irrespective of gender and socio-economic status.
2. PTB subjects after completion of DOTS treatment protocol.
3. Subjects willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Pregnant women and lactating mother with PTB.
2. PTB subjects who are under treatment.
3. PTB subjects with diabetes mellitus.
4. Extrapulmonary TB and Surgical PTB cases
5. HIV and PTB coinfection
6. PTB subjects infected with STDs. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in physical health and less symptoms compared to control group  45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Maintanence of imporved in physical health and less symptoms compared to control group  90th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   03/03/2025 
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="1"
Months="6"
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 - NO
Brief Summary  
NEED FOR STUDY
Swasthasya Swasthyarakshanam, Aturasya Vikaraprashamanam, is the main aim of Ayurveda which describe the importance of maintaining and promoting the health in addition to treating illness.
Diseases are destroyers of health and well being, which is infectious, communicable and health deteriorating are explained in Ayurveda.
Rajayakshma is one of them which is considered aupsargika vyadhi (communicable disease) and also is asadhya as it is associated with loss of strength and muscle wasting due to kshaya.
Sahasa, vega sandarana, kshaya, vishamashana, are the four causes of rajayakshma and shows its symptoms like pinasa, shwasa, kasa, aruchi, vitsamsrana, chardi all leads to kshaya or shosha of the body.
Rajayakshma can be correlated with pulmonary tuberculosis in modern science, in which the rasadi dhatus gets diminished, leading to decreased strength and activity levels, it is also known as rogarat, the king of diseases, governing all other illnesses.
In 2023, incidence of TB increased slightly to 27.8 lakh from the previous year’s estimation of 27.4 lakh.
The disease itself and DOTS treatment can diminish the physical health of the patient and is a challenging task for the physician to revive undernourished health into normalcy and also to prevent the recurrency of the infection due to impaired immunity. Even the government provides monthly support of Rs.500 to nearly 1crore beneficiaries for undernourished TB patients estimated 7.44 lakh as reported in 2022.
In Ayurveda, to treat the undernourishment in PTB infected person, numerous methods and medications has been indicated. One such formulation explained in bhaishajya ratnavali is draksharishta as balya.
Hence, this is a trial taken to see the effect of draksharishta in treated cases of PTB to improve and promote the physical health status particularly focusing on weight and physical attributes.

AIMS & OBJECTIVE OF THE STUDY
1. To evaluate the effect of draksharishta as physical health promoter in treated cases of PTB
2. To evaluate the physical health of the wait list subjects in treated cases of PTB.
3. To compare the efficacy of draksharishta and wait list subjects in treated cases of PTB

SAMPLE SIZE:
30 subjects diagnosed with PTB (irrespective of gender) and completed Treatment protocol will be taken into 2 groups based on randomized sampling method.
Group A-15 subjects (wait list group)
Group B-15 subjects (interventional group)

PLAN OF TREATMENT:
GROUP A: Sample Size- 15 subjects(wait list group)
GROUP B:
Sample size- 15 subjects(interventional group)
Subjects after fulfilling the criteria and after taking informed consent.
Draksharishta will be procured from GMP certified pharmacy and will be given in Dose-25ml BD after food with equal quantity of water for 45days.

ASSESSMENT CRITERIA:
Subjects will be assessed before and at the end of the month on 0th day, 15th day, 30th day, 45th day and follow up on 90th day by using following scales

OBJECTIVE:
1. Weight
2. BMI
3. Mid Arm circumference
4. Skin fold thickness
 
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