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CTRI Number  CTRI/2025/03/081614 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pushkarmoola and Erandamoolas comparative effectiveness as an add on therapy for tuberculous plueral effusion 
Scientific Title of Study   Comparative Clinical Efficacy Of Pushkarmoola (Inula racemosa Hook.f) And Its Pratinidhi Dravya Erandamoola (Ricinus communis L.)As An Add On Therapy In Tuberculous Pleural Effusion. 
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. Nupoorkumari A Patel 
Designation  MD Scholar 
Affiliation  Government Ayurved College and Hospital, Vadodara 
Address  Government Ayurved College and Hospital, Outside Panigate, Opp. Panigate Depot, Vadodara, Gujarat 390019

Vadodara
GUJARAT
390019
India 
Phone  9624148759  
Fax    
Email  nupoor28patel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Singh 
Designation  Assistant professor 
Affiliation  Government Ayurved College and hospital, Vadodara 
Address  Government Ayurved College and Hospital Outside Panigate, Opp. Panigate Depot, Vadodara, Gujarat 390019

Vadodara
GUJARAT
390019
India 
Phone  95101722024  
Fax    
Email  snghsmn@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrAnand Patel 
Designation  Assistant professor 
Affiliation  GMERS Medical College and hospital, Gotri, Vadodara 
Address  Dept. of Pulmonary medicine, GMERS Medical College and hospital, Gotri, Vadodara 391101

Vadodara
GUJARAT
391101
India 
Phone  9879771079  
Fax    
Email  dranandkpatel@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved college and Hospital, Ajwa road, Dhanwantari marg,Panigate, Vadodara, 390019 
 
Primary Sponsor  
Name  Government Ayurved college and Hospital,Vadodara 
Address  Government Ayurveda college and Hospital, Outside Panigate, Opp. Panigate Depot, Vdodara,Gujarat 390019 
Type of Sponsor  Research institution and hospital 
 
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 Anand Patel  GMERS, Medical College and Hospital Gotri, Vadodara  Opd No.206,Dept. of Pulmonary medicine, GMERS Medical College and hospital, Gotri, Vadodara 391101
Vadodara
GUJARAT 		 09879771079

dranandkpatel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Ayurved College and Hospital, Vadodara   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J90||Pleural effusion, not elsewhere classified. Ayurveda Condition: PARSVARUJAH/PARSVASULAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Pushkarmoola, Reference: Vrindamadhava 31/12, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Honey), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Erandamoola, Reference: -, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: honey), Additional Information: -
3Comparator Arm (Non Ayurveda)-standard AKT as per standard protocol
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosed case of mild and moderate pleural effusion in Tuberculosis 
 
ExclusionCriteria 
Details  Pleural effusion associated with malignancy, cirrhosis of liver, HIV.
Patient with major systemic illness which intervened the course of treatment
Pregnant and lactating women  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary- Reduction in symptoms
 		 4week
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary- non recurrence of condition and improvement in quality of life  1 week 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   18/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study is randomized clinical trial to comparative clinical efficacy of Pushkaramoola and its pratinidhi dravya Erandamoola as an add on therapy in Tuberculous Pleural effusion. Total 45 patient will  enrolled in present study divided in three groups on the basis of computer generated randomization. In this study churna of Pushkarmoola and Kwath of Erandamoola with sahapana of Honey thrice in a Day for Four week. Follow up for 1 week. Clinical data obtained will e summarized at the end of study. Conclusion will e made after the statistical analysis of data.  
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