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CTRI Number  CTRI/2017/03/008096 [Registered on: 15/03/2017] Trial Registered Prospectively
Last Modified On: 05/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study for the management of Urolithiasis 
Scientific Title of Study   CliniHajarulayahuda Bhasma in the mancal Evaluation of Shvadamshtradi Kashaya and agement of Mutrashmari (Urolithiasis) 
Trial Acronym  Shvadamshtradi Kashaya, Hajarulayahuda Bhasma 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr T Maheswar 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Regional Ayurveda Research Institute for Skin Disorders New Rajiv nagar Payakapuram Vijayawada

Krishna
ANDHRA PRADESH
520015
India 
Phone  9441415266  
Fax    
Email  mahesh_rri@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Maheswar 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Regional Ayurveda Research Institute for Skin Disorders New Rajiv nagar Payakapuram Vijayawada


ANDHRA PRADESH
520015
India 
Phone  9441415266  
Fax    
Email  mahesh_rri@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr T Maheswar 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Regional Ayurveda Research Institute for Skin Disorders New Rajiv nagar Payakapuram Vijayawada


ANDHRA PRADESH
520015
India 
Phone  9441415266  
Fax    
Email  mahesh_rri@yahoo.co.in  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences JLNBCEH Anusandhan Bhawan Institutional Area Opposite D Block Janak puri New Delhi - 58 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Jawahar lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi - 110058  
Type of Sponsor  Research institution 
 
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 T Maheswar  Regional Ayurveda Research Institute for Skin Disorders  Regional Ayurveda Research Institute for Skin Disorders Room No 207, 3rd Floor New Rajiv nagar Payakapuram Vijayawada
Krishna
ANDHRA PRADESH 
9441415266
08662402144
mahesh_rri@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Urolithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Shvadamshtradi Kashaya and Hajarulayahuda Bhasma   Shvadamshtradi Kashaya (Ref: Chakradatta, Asmari Chikitsa – 34/28) Dose : 50 ml once a day Dosage form: Decoction Route of Administration: Oral Time of Administration : Once a day before food Duration of therapy:12 weeks And Hajarulayahuda Bhasma (Ref:AFI 14:4) Dose : 500 mg bd Dosage Form:Powder Anupana :Luke warm water Route of Adminstration : Oral Time of Adminstration : Twice a day after food Duration of Therapy:12weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either sex with age between 18 and 60 years
2.Patients presenting with or without symptoms of urolithiasis.
3.Radiological evidence of calculi(upto 7 mm)
In kidney/ ureter /urinary bladder
 
 
ExclusionCriteria 
Details  1.Age below 18 years and above 60 years
2.Calculi size more than 7 mm
3.Impacted calculi
4.Gross hydronephrosis, Pyelonephritis, Renal failure
5.Patients having serum creatinine >1.5 mg/dl
6.Patients who cannot report in person every 2 weeks in the OPD
7.Patients with poorly controlled Hypertension ( >160/100 mmHg)
8.Patients with poorly controlled Diabetes Mellitus having
Hb A1C of > 7.5%
9.Patients on medication with any other drugs that
may have an influence on the outcome of the study.
10.Known case of cardiovascular diseases
11.Known HIV positive cases
12.Patients with concurrent serious hepatic disorder
(defined as Aspartate Amino Transferase (AST) and / or
Alanine Amino Transferase (ALT), Total Bilirubin,
Alkaline Phosphatase (ALP) > 2 times upper normal limit),
Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and /
or Chronic Obstructive Pulmonary Disease [COPD]),
or any other condition that may jeopardize the study.
13.Alcoholics and/or drug abusers
14.H/o hypersensitivity to any of the trial drugs or their ingredients
15.Pregnant/lactating woman.
16.Patients who have completed participation in any other clinical trial during the past six months.
17.Any other condition which the Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Radiological disappearance or reduction of calculi size  12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Relief in Signs & Symptoms of Mutrashmari  12 weeks  
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   01/04/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Will be published after completion of the study 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In Ayurveda  Asmari (Urolithiasis) is well described in Charaka, Susrutha Samhitha with its etiopathogenesis, clinical features, type and prognosis. Vagbhata explained ashmari as one of the Asta maha gada. Asmari has been derived from the “Asman” Sanskrit word which literally means a structure resembling stone. It has been described that due to unwholesome diet and living habits aggravated kapha reaches in urinary tract dries up and forms the calculus and suppression of urge to passing urine resulting in crystallization and precipitate into calculus formation. There is colicky pain in bladder, anorexia, dysuria, fever, physical lassitude, goat like smell in urine and an excruciating pain in the neck of the bladder, scrotum indicate the formation of the urinary calculus. In Vataja variety stone resembles dusky in colour, hard, irregular, rough, nodular and spiny like kadambha flower & Patient feels severe pain, difficulty in passing urine, flatulus and stool. In pittaja variety stone resembles Marking nut seed shape, Yellowish black, blood mixed, honey coloured and patient feels burning sensation, warm feeling over bladder and sucking type of pain. In kaphaja variety stone resembles madhuka puspa in colour, unctuous, large sized like hen’s egg & patient feels dysuria, prickling and incising pain and heaviness and cold sensation over bladder region. On this disease a  series of clinical Research Trials have been conducted for the evaluation of certain medicinal preparations in different stages of the disease effectively with Hajarulayahuda Bhasma, Pashanabhedadi ghrita, Kulattadi yoga, Vvarunadi kwatha, Pashanabhedadi kwatha, Ashmari hara kwatha, gokshuradi guggulu etc. This study has been planned to evaluate the efficacy and safety of  Shvadamshtradi Kashaya and Hajarulayahuda bhasma. These drugs will be given for 12 weeks. This study will be conducted at OPD of Regional Ayurveda Research Institute for Skin Disorders, Vijayawada.  

 
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