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CTRI Number  CTRI/2023/07/054784 [Registered on: 05/07/2023] Trial Registered Prospectively
Last Modified On: 04/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Investigating the effect and safety of NEERI® Tablet and Syrup on kidney stones 
Scientific Title of Study   An open-label, randomized, single center prospective study to evaluate the efficacy & safety of a polyherbal NEERI® Tablet and Syrup in patients with renal calculi disease 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AIMIL/001/2023 Version No. 1.0 Dated 27 May 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SSVV Narasinga Rao 
Designation  Assistant Professor  
Affiliation  Govt. Medical Collège & Govt. General Hospital 
Address  Govt. Medical Collège & Govt. General Hospital Research wing 2nd Floor, Beside FM Ward, Srikakulam- 532001, Andhra Pradesh- India.

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  9908611119  
Fax    
Email  drnarasingaraossvv@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd 
Address  #252,13th Cross, Wilson Garden, Bengaluru Karnataka

Bangalore
KARNATAKA
560027
India 
Phone  9886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Details of Contact Person
Public Query  
Name  Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd 
Address  #252,13th Cross, Wilson Garden, Bengaluru Karnataka

Bangalore
KARNATAKA
560027
India 
Phone  9886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Source of Monetary or Material Support  
Aimil Pharmaceuticals (India) Ltd. 
 
Primary Sponsor  
Name  Aimil Pharmaceuticals (India) Ltd. 
Address  2994/4, Street no. 17, Ranjeet Nagar, Patel Nagar, New Delhi – 110008  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 SSVV Narasinga Rao  Government Medical College & Government General Hospital   Research wing 2nd Floor, Beside FM Ward, Srikakulam- 532001, Andhra Pradesh- India.
Srikakulam
ANDHRA PRADESH 		 9908611119

drnarasingaraossvv@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: MUTRAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: NEERI Tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 630(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -NA
2Intervention ArmDrugOther than Classical(1) Medicine Name: NEERI Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -NA
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Participants of either sex aged 18 to 65 years
2.Willing to sign informed consent and comply with the requirements of the study protocol
3.Participants with diagnostic reports (plain X-ray, ultrasound sonography, or CT scan) for renal calculi.
4.Participants with the calculi size ranging from 4 mm to less than 10 mm.
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women
2.Known allergies to any component of the study intervention.
3.Patients with acute or complicated conditions of kidney stones.
4.Subjects who have taken other drugs or herbal supplements for stone disease in the previous 3 months.
5.Participants with chronic or active disease, such as kidney failure, liver disorder, cancer, myocardial infarction, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, and chronic kidney infection.
6.Evidence of significant concomitant disease that, in the view of the principal investigator, that would prevent patient participation
7.Participants suffering from a mental illness or other condition that would make it difficult to meet the study requirements.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•Change in the size of renal stones from baseline to end of the study assessed by using ultrasound sonography (USG).
•Change in the number of renal stones from baseline to end of the study assessed by using USG.
 		 day -2, day 0, day 60, day 120 
 
Secondary Outcome  
Outcome  TimePoints 
•Mean change in the symptom severity score from screening to end of the study
•Mean changes in the levels of serum calcium, serum phosphorous, serum magnesium & serum uric acid and oxalate in urine from screening to end of the study
•Mean changes in the vital signs from screening to end of the study.
•Mean changes in the serum levels of BUN and Sr. creatinine from screening to end of the study
•Mean changes in the serum levels of SGPT and SGOT from screening to end of the study
•Mean changes in the CBC parameters from screening to end of the study
•Occurrences and frequencies of adverse and serious adverse events during the study period
 		 day -2, day 0, day 60, day 120 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   20/07/2023 
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="0"
Months="8"
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   Urinary calculi (stones) are solid crystalline masses that form in the urinary tract. Urinary stones affect approximately 2-5% of the Asian population, and the risk of recurrence is also high. Approximately 60–85% of human stones are calcium oxalate, calcium phosphate, or both. Several factors influence kidney stone formation, including metabolic changes, lack of stone-inhibiting factors, and salt-saturated urine status .NEERI® Tablet and Syrup are the polyherbal formulations for the treatment of various renal problems, including renal calculi, urinary tract infections (UTIs), dysuria, and benign prostatic hyperplasia.
An open-label, randomized, single center prospective study to evaluate the efficacy and safety of a polyherbal NEERI® Tablet and Syrup in patients with renal calculi disease.The study will last approximately 120 days (4 months). Each patient will receive 120 days of treatment. A total of 30 evaluable subjects are planned to enrol in this study. Recruitment and treatment of subjects is expected to be performed in a single study center. According to the randomization code, eligible patients will be assigned in a 1:1 ratio to one of the study groups, i.e., each group will have 15 subjects.
 
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