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CTRI Number  CTRI/2024/09/074296 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [UTTARBASTI AND MATRA BASTI ALONG WITH ORAL MEDICINE]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of Mootraghata ( benign prostate hyperplasia ) treated with Uttar Basti and oral medication to give relief from the Mootraghata ( benign prostate hyperplasia ). 
Scientific Title of Study   Comparative clinical effect of Varunadhya Taila Uttar Basti and Matra Basti along With Kanchanara Guggulu orally in the management of Mootraghata wsr benign prostatic hyperplasia - an open labelled randomized clinical study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Keyur Rajeshbhai Chudasama 
Designation  Second Year Pg Scholar 
Affiliation  Shree Swaminarayan Ayurvedic Collage 
Address  3rd Floor, Post Graduation Department Of Shalya Tantra, Shree Swaminarayan Ayurvedic Collage, Ahmedabad- Mehsana Highway, At p.o. Saij, Kalol, Gandhinagar. Gujarat

Gandhinagar
GUJARAT
382721
India 
Phone  9033359321  
Fax    
Email  keyur1941@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Patel 
Designation  Professor 
Affiliation  Shree Swaminarayan Ayurvedic Collage 
Address  3rd Floor, Post Graduation Department Of Shalya Tantra, Shree Swaminarayan Ayurvedic Collage, Ahmedabad- Mehsana Highway, At p.o. Saij, Kalol, Gandhinagar. Gujarat

Gandhinagar
GUJARAT
382721
India 
Phone  9176945090  
Fax    
Email  dranitasudha@swaminarayanuniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Neeraj Kumar 
Designation  Professor 
Affiliation  Shree Swaminarayan Ayurvedic Collage 
Address  3rd Floor, Post Graduation Department Of Shalya Tantra, Shree Swaminarayan Ayurvedic Collage, Ahmedabad- Mehsana Highway, At p.o. Saij, Kalol, Gandhinagar. Gujarat

Gandhinagar
GUJARAT
382721
India 
Phone  7231053235  
Fax    
Email  doctorneerajsharma@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway, At.& Po. Saij, Ta.Kalol, Dist. Gandhinagar-392725 
 
Primary Sponsor  
Name  Premswarup Swami Ayurvedic Multi Speciality Hospital Kalol 
Address  Shree Swaminarayan Ayurvedic College Premswarupswami Ayurvedic multispeciality Hospital Ahmedabad-Mehsana Highway At and Po.Saji Ta.Kalol Dist.Gandhinagar-382725 
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 Keyur Rajeshbhai Chudasama   Premswarup Swami Ayurvedic Multi Speciality Hospital  OPD 006 Department of Shalya tantra, Premswarup Swami Ayurvedic Multispeciallity Hospital, Ahmedabad-Mehsana highway At.& Po. Saij,Ta Kalol,Dist. Gandhingar-382725 Gandhinagar GUJARAT
Gandhinagar
GUJARAT 		 9033359321

keyur1941@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Shree Swaminarayan Ayurvedic Collage And Hospital, Kalol.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: MUTRAGHATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Sushruta Samhita. Chikitsa Sthana, Anuvasnotarbasti Chikitsa Adhyay, Procedure details: PROCEDURE OF UTTAR BASTI PURVA KARMA: Vitals (TPR, BP, and SpO2) of the patient will be taken. Informed written consent will be taken. An information sheet will be provided to all patients at the time of registration. All the basti material, i.e., Varunadhya Taila, 20 ml and 2.5 ml syringes, feeding tubes no. 8 or 10 (as per requirement), betadine solution, gauze piece, Xylocaine jelly 2%, sponge holding forceps, and sterile cut sheet, will be kept ready on a tray. PRADHAN KARMA: The patient will be taken into a supine position on the OT table. Under all aseptic precautions, local part preparation with Abhyanga and Swedana will be done. Hold the penile circumferential area and insert xylocaine jelly with a 2.5-ml syringe. Then, with the help of a 20-ml disposable syringe and feeding tube (size will be as per requirement), Varunadhya Taila will be slowly inserted through the urethra. PASHCHAAT KARMA: For holding the drug in situ, hold the penile area until the instilled tail doesn’t flow back from the urethra. Cleaning of the penile area will be done. After taking vitals again, the patient will be shifted to the ward for observation for 30 minutes. )
(1) Medicine Name: Varunadhya Taila , Reference: Bhaisajya Ratanavali, mutrakruchhchachikitsa, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 14 Days
2Comparator ArmDrugClassical(1) Medicine Name: Kanchanara guggulu, Reference: sarngadhara-samhita madhyama khanda, adhyay no. 7, vatakakalpana slok no. 94-100, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Luke warm water ), Additional Information: -
3Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Sushruta Samhita. Chikitsa Sthana, Anuvasnotarbasti Chikitsa Adhyay, Procedure details: PROCEDURE OF MATRA BASTI PURVA KARMA: Vitals (TPR, BP, & SpO2) of the patient will be taken. Informed written consent will be taken. An information sheet will be provided to all patients at the time of registration. All the Basti materials are ready on the tray, i.e., Varunadhya Taila, 60-ml syringe, red rubber catheter, betadine solution, gauze piece, and transpore tape. PRADHAN KARMA: The patient will be taken in a left-lateral position. Locally, abhyanga and swedana will be done, and then, with the help of a syringe, 60 ml of Varunadhya Taila will be slowly instilled in the rectum with the help of a red rubber catheter. PASHCHAAT KARMA: Rest for some time will be advised in the same position. After taking vitals again, the patient will be shifted to the ward for observation for 30 minutes ))
(1) Medicine Name: Varunadhya Taila, Reference: Bhaisajya Ratanavali,adhyay no. 34 mutrakruchhchachikitsa slok no. 68, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1.The patients having three or more signs from the diagnostic criteria (Benign Prostatic Hyperplasia).
2. blood pressure between 80 and 60 mmHg to 140 and 90 mmHg;
3. RBS below 140 mg/dl
4. As per the USG study, retention of urine with residual urine less than 200 ml.
5. Prostate size less than 200 cc.
6. Uttarbasti-arha. 
 
ExclusionCriteria 
Details  1. Patients less than 40 years and more than 70 years
2. Patients with malignancy, congenital deformities of the urogenital tract, or any abdominal-pelvic pathology other than BPH
3. Systemic diseases like chronic renal failure CRF, uncontrolled hypertension BP is more than 150 by 90 of mmHg, diabetes mellitus RBS greater than 150 mg by dl,
4. Patients with hematuria and urolithiasis have localized infections.
5. Patients with chief complaints of tuberculosis, paralysis, or Parkinsonism will be excluded.
6. Known cases of cardiac diseases History Of MI, IHD.
7. Patient is HIV, HBsAg, HCV, or VDRL positive.
8. Chronic retention of urine with residual urine of more than 200 ml
9. Prostate size more than 200 cc.
10. Complications such as hydroureter, hydronephrosis, stone formation, recurrent infection, bladder changes, Stricture urethra, Prostate carcinoma, idiopathic bladder neck obstruction, bladder neck hypertrophy, and haematuria
11.bastianarha 
 
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 
Relief in the clinical symptoms of Mootraghata (Benign Prostatic Hyperplasia).  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease In Size Of Prostate  21 DAYS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/10/2024 
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="2"
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  

In mutravaha strotas vikaras, the line of treatment is basti chikitsa. So to check which kind of basti chikitsa shows better result, I took this condition as an opportunity. After completing this study, the results will be helpful in future to make standard treatment protocol for BPH.

In this study, I will give uttarbasti and matrabasti in to two different groups and also give kanchanara guggulu with luke warm water. The expected outcome of this study is to get symptomatic relief from the BPH. After completion of the study the conclusion will be made.

 
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