CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 07:49:14 GMT) CTRI Number CTRI/2019/07/020164 [Registered on: 12/07/2019] - Trial Registered Prospectively Last Modified On 10/07/2019 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Ayurveda Study Design Randomized, Parallel Group Trial Public Title of Study A Comparative clinical Study of Medicated Oil Enema by two different route of administration in Benign Prostate Hyperplasia Scientific Title of An Open Lable Comparative Clinical Study Of Shilodbidadi Taila Uttara-Basti And Matra Basti In Study Mutraghata( B P H) Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Veeresh Sattigeri Trial Coordinator (multi-center study) Designation Assistant Professor Affiliation RGES Ayurvedic Medical College Ron Address RGES Ayurvedic Medical College Department of Shalya Tantra Division A Room Number -7 First Floor Abbigeri Road Ron Gadag KARNATAKA 582209 India Phone 8748977781 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Veeresh Sattigeri Query) Designation Assistant Professor Affiliation RGES Ayurvedic Medical College Ron Address RGES Ayurvedic Medical College Department of Shalya Tantra Division A Room Number -7 First Floor Abbigeri Road Ron Gadag KARNATAKA 582209 India Phone 8748977781 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr S A Patil Designation Assistant Professor Affiliation Ayurveda Mahavidyalaya Hubli Address Ayurveda Mahavidyalaya Hubli Department of Shalya Tantra Division A Ground Floor Room Number 8 Heggeri Extension Hubli Dharwad KARNATAKA 580024 India page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 9448565198 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Ayurveda Mahavidyalaya Hubli Department of Shalya tantra Room Number 8 Division A Heggeri Extension Hubli District Dharwad PIN 580024 Primary Sponsor Primary Sponsor Details Name Dr Veeresh Sattigeri Address Ayurveda Mahavidyalaya Hubli Heggeri Extension Hubli District Dharwad 580024 Type of Sponsor Other [Primary Investigator] Details of Secondary Name Address Sponsor Dr S A Patil Ayurveda Mahavidyalaya Hubli Department of Shalyatantra Heggeri Extension Hubli pin 580024 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Veeresh Sattigeri Ayurveda Department of Shalya 8748977781 Mahavidyalaya Hubli tantra Ground Floor Room Number 8 [email protected] Heggeri Extension m Hubli 580024 Dharwad KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethical Committee Approved 29/06/2018 No Ayurveda mahavidyalaya Hubli Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Benign prostatic hyperplasia without lower urinary tract symptoms Intervention / Type Name Details Comparator Agent Intervention Group A Uttarabasti Medicine : Shilodbhidadi taila Dosage : 60ml Time : Once in day(Approximately 9am to 10am) Duration : 8 days Gokshura kwatha orally: 30 ml bd 2 month from the day 1 of the treatment. Intervention Group B Matrabasti Medicine : Shilodbhidadi taila Dosage : 60ml Time : Once in day(Approximately 9am to 10am) Duration : 8 days Gokshura kwatha orally: 30 ml bd 2 month from the day 1 of the treatment. Comparator Agent Group C Gokshuradi Kwatha Medicine: Gokshura kwatha page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Oral Dosage : 30 ml Time : twice in day Duration: 30ml bd 2 months Inclusion Criteria Inclusion Criteria Age From 50.00 Year(s) Age To 70.00 Year(s) Gender Male Details Patients with the clinical features of BPH (I-PSS Index) Patients fit for Uttara basti and Matra basti Digital rectal examination findings (BPH) Ultrasonography findings suggestive of BPH. Post voidal Residual urine volume more than 60 ml. Uroflowmetry less than 15ml/sec. Patient of Diabetes Mellitus less than 10 years of duration Exclusion Criteria Exclusion Criteria Details Patients with other causes of Uretheral stricture, Meateal Stenosis, phymosis calculus, Sexual transmitted disorders Un control Diabetic mellitus patients HIV, HBsAg, patients, any prostate cysts, Acute urine retention, Heamaturia, significant bladder tenderness. Method of Generating Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Efficacy of Shilodbidai Taila Uttarabasti and 1st day and 60th day of study Matrabasti in the management of Mutraghata Secondary Outcome Outcome Timepoints Comparison of efficacy of Shilodbidai taila in the 1st day and 60th day form of Uttarabasti and Matrabasti in the management of Mutraghata Target Sample Size Total Sample Size=120 Sample Size from India=120 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 1 Date of First 01/10/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=4 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Nil Brief Summary Benign Prostatic Hyperplasia (BPH) is a most common lower urinary tract disorder and it is the burning senile problem of elderly men of age group between 50 to 70 years. The Incidence rate of BPH increase from 3 cases per 1000 men per year at the age 45–49 years, 38 cases per 1000 page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in men per year by the age of 75–79 years which shows the vulnerability of the disease at terminal age. The treatment options in modern medicine by conservative treatment using drugs i.e hormonal therapy has its complications like loss of libido, impotency, gynecomastia etc surgical intervention like open prostatectomy, Transurethral resection of Prostate (TURP), cryotherapy, Radio frequency obliation,HIFU (high intensity focal ultrasound) etc have their own limitations . Hence There is a increasing interest in less invasive techniques, and to find out a suitable Ayurvedic approach, an effort has been made towards the management of BPH. Considering the line of management, the treatment methods which are adopted for Mutra vikaras, as Abhyanga, Niruha Basti, Snehapana, Uttara Basti, Seka, Pradeha, Virechana etc are advised for all varieties of Mutraghata The Shilodbhidadi Taila is indicated in Mutrakricchra, Mutraghata, Asmari Chikitsa in the textbook of Bhaishajya ratnavali which is best Vatahara, Balya, shota hara and Vedana shyamaka With regard to this Shilodbhidadi taila is considered for this present clinical study as Uttara basti and Matra basit in Mutragatha (BPH) page 4 / 4 Powered by TCPDF (www.tcpdf.org).

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