FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/07/020305 [Registered on: 22/07/2019] Trial Registered Prospectively
Last Modified On: 20/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Preventive
Other (Specify) [Curative]  
Study Design  Single Arm Study 
Public Title of Study   Clinical study of Unani drug in kidney stone 
Scientific Title of Study   THERAPEUTIC EVALUATION OF A UNANI PHARMACOPOEIAL FORMULATION – DAWA-E-GURDA IN HASÄ€H AL-KULYA (NEPHROLITHIASIS): A SINGLE ARM, OPEN LABEL, PROSPECTIVE CLINICAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Makula Swathi 
Designation  PG Scholar 
Affiliation  Central Research Institute Of Unani Medicine - Hyderabad. 
Address  Dept. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hosptial, AG Colony Road, Erragadda, Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  6300034959  
Fax    
Email  iamdrswathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Qamar uddin 
Designation  Professor 
Affiliation  Central Research Institute Of Unani Medicine - Hyderabad. 
Address  Central Research Institute of Unani Medicine, A.G-Colony Road,opposite ESI hospital,Erragadda,Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Nawab 
Designation  Research Officer 
Affiliation  Central Research Institute Of Unani Medicine - Hyderabad. 
Address  Central Research Institute of Unani Medicine, A.G-Colony Road,opposite ESI hospital,Erragadda,Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8100992044  
Fax    
Email  ccrumnawab@gmail.com  
 
Source of Monetary or Material Support  
Central Research Institute of Unani Medicine Hyderabad 
 
Primary Sponsor  
Name  Central Research Institute of Unani Medicine Hyderabad 
Address  Central Research Institute of Unani Medicine, A.G-Colony Road,opposite ESI hospital,Erragadda,Hyderabad 500038 
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 
Makula Swathi  Central Research Institute of Unani Medicine, Hyderabad.  Moalajat OPD No. 2, Ground Floor, New OPD Block, CRIUM, A.G-Colony Road, Erragadda, 500038
Hyderabad
TELANGANA 
6300034959

iamdrswathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, CRIUM - Hyderabad  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dawa-e-Gurda (Powder)  Dawa-e-Gurda (Powder)in the dose of 3gm twice daily with water after meals. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients of any sex aged 18-65 years
2) Patients with Hasāh al-Kulya (nephrolithiasis) diagnosed by Plain X-Ray Abdomen (KUB)/ Ultrasound Abdomen
3) Stone in Renal Pelvis with size ranging from 5-9 mm
4) Patients with or without any of the following symptoms:
-Bawl al-Dam (Haematuria)
-Siql al-Khāsira (Heaviness in the Loin)
-Waja‘ al-Khāsira (Pain in the Loin)
-Urine showing Calcium Crystalluria
-History of Recurrent UTI
-History of Recurrent Nephrolithiasis
5) Patients willing to give written informed consent
6) Patients willing to comply with the requirements of the study protocol
 
 
ExclusionCriteria 
Details  1) Patients aged less than 18 or more than 65 years
2) Patients having acute renal colic
3) Complicated cases of nephrolithiasis requiring surgical intervention
4) Patients with hydronephrosis, acute symptoms of UTI or any other kidney disease, including serum creatinine level more than 1.5 x ULN or eGFR less than 60 mL/min
5) Liver dysfunction, defined as serum bilirubin more than 1.5 x ULN, SGOT (AST) or SGPT (ALT) more than 2.5 x ULN
6) Known cases of significant cardiac/ pulmonary dysfunction or immunocompromised states (HIV/ AIDS, etc.)/ malignancies
7) Patients on long-term medications
8) Pregnancy and lactation
9) Currently active alcohol or drug abuse/ history of alcohol or drug abuse within 6 months prior to baseline
10) Known sensitivity to study medication or any of its ingredient
11) Patient not willing to attend treatment schedule regularly
 
 
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 
1) Stone Size on Ultrasound (KUB)
2) Renal Pain and Loin Heaviness
3) Visual Analogue Scale (VAS)
4) Relief in Bawl al-Dam (Haematuria)


 
USG at Baseline and 8th week.
Rest at Baseline, 2nd week, 4th week, 6th week, 8th week
 
 
Secondary Outcome  
Outcome  TimePoints 
Lab Investigations  Baseline and after treatment. 
 
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   Phase 2 
Date of First Enrollment (India)   05/08/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/08/2019 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Hasāh al-Kulya (Nephrolithiasis), or kidney stone disease, is a common,
painful condition, having a substantial economic impact. Each year,
billions of dollars are spent on the nephrolithiasis-related activity, with the
majority of expenditures on surgical treatment of existing stones.
Infectious stones, if not appropriately treated, can have devastating
consequences and lead to end-stage renal disease. Globally, its
incidence is increasing; an analysis from India shows an increase from
0.9% to 9.0% over 20 years. Once an individual has had a stone, the
prevention of a recurrence is essential. 1
The goals of nephrolithiasis treatment are to remove the stone, reduce the

3
damage incurred by growth and spread of stones, and prevent its
recurrence. Therapies in modern system of medicine for expulsion and
prevention of recurrence of nephrolithiasis are ineffective. Certain drugs
may help the stone to pass, but they have frequent and serious adverse
effects.
Treating nephrolithiasis with thiazides may induce hypokalaemia,
hypomagnesaemia, hyperuricaemia, hyperglycaemia, and
hyperlipidaemia. Thiazide-induced hypokalemia will reduce urine citrate,
an important inhibitor of calcium crystallization (secondary
hypocitraturia), and leading to stone formation. Moreover, the drug
(thiazide) effect requires a slight contraction of the extracellular fluid
volume, and high dietary NaCl intake reduces its therapeutic effect.
Acetohydroxamic acid, an inhibitor of urease is used to treat struvite
stones, but it has many side effects, such as headache, tremor, and
thrombophlebitis, that limits its use. Although penicillamine or tiopronin
are effective in the treatment of cystine stones, but the ability of these
treatments to reduce stone frequency is not quantitatively known.
However, they exhibit a high rate of intolerance due to severe side
effects, such as abdominal pain, loss of taste, fever, proteinuria, and,
nephritic syndrome. Allopurinol is used in calcium and uric acid stones,
but it inhibits xanthine oxidase leading to xanthine stone formation. 2
Currently, surgical procedures and extra-corporeal shock wave lithotripsy
(ESWL) are commonly employed in the management of nephrolithiasis.
With lithotripsy, residual stones are left in 35-50% of cases having
stones of >2 cm, or >1 cm in the lower poles; and lithotripsy disrupts
cystine stones poorly. 2 Moreover, the major drawback of these
procedures is a recurrence of renal calculi. Most of the patients who
undergo a surgical procedure for removal of renal calculi refuse to undergo
a similar procedure again and again. For them, drugs that would remove
renal calculus and would prevent recurrence are required.
Unani drugs having lithotriptic activity as such may not replace surgically
procedures but may help in preventing the recurrence of nephrolithiasis.
Unani Pharmacopoeial formulation – Dawa-e-Gurda has been used by
the Unani physicians since decades for the treatment of Hasāh al-Kulya
(Nephrolithiasis), but no scientific data regarding its safety and efficacy
are available. Keeping this in view, this study has been planned to
evaluate the safety and efficacy of an Unani Pharmacopoeial formulation
– Dawa-e-Gurda in the treatment of Hasāh al-Kulya (Nephrolithiasis).
 
Close