FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/06/053971 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 04/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Chandraprabha Vati along with Gokshuradi Guggulu in patients of Benign Prostatic Hyperplasia (BPH)  
Scientific Title of Study   Evaluation of the efficacy & safety of ChandraprabhaVati with Gokshuradi Guggulu in the management of benign prostatic hyperplasia- A randomized, standard controlled clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aaditya Bhavanbhai Shah 
Designation  Research Officer (Ay.) 
Affiliation  Regional Ayurveda Research Institute, (Central Council for Research in Ayurvedic Sciences) Jammu 
Address  Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu-181123.

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9033236720  
Fax    
Email  dr.aaditya.shah@gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Aaditya Bhavanbhai Shah 
Designation  Research Officer (Ay.) 
Affiliation  Regional Ayurveda Research Institute, (Central Council for Research in Ayurvedic Sciences) Jammu 
Address  Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu-181123.

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9033236720  
Fax    
Email  dr.aaditya.shah@gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Aaditya Bhavanbhai Shah 
Designation  Research Officer (Ay.) 
Affiliation  Regional Ayurveda Research Institute, (Central Council for Research in Ayurvedic Sciences) Jammu 
Address  Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu-181123.

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9033236720  
Fax    
Email  dr.aaditya.shah@gov.in  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Goverment of India 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Goverment of India 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No.61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 ( India ) Telephone : 91-011-28525862/28525897/28525852 Fax : 91-011-28520748/28525959 (Office of the DG) 
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 Aaditya Bhavanbhai Shah Research Officer Ay  Regional Ayurveda Research Institute, Jammu  Room No. 102, first floor (Block A), Regional Ayurveda Research Institute, Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India, Rajinder Nagar, Bantalab, Jammu-181123
Jammu
JAMMU & KASHMIR 		 9033236720

draaditya.shah@gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, RARI, Jammu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N40||Benign prostatic hyperplasia. Ayurveda Condition: VATASHTHILA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Chandraprabha Vati, Reference: AFI, Part-I, 12:10 Pg. 185, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Gokshuradi Guggulu , Reference: API, Part - II (Formulations) Volume – II First Edition, Pg. 157, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Tamsulosin HydrochlorideTab. Tamsulosin Hydrochloride •Dose: 01Tablet of 0.4 mg tamsulosin hydrocloride •Route of Administration: Oral •Time of Administration: once daily after food •Duration of therapy: Three Months (90 days)
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1. Prostate volume > 20 and ≤ 50 gm by Transabdominal ultrasound
2. Newly diagnosed case of BPH or who have discontinued any other medication for BPH or related complaints for minimum three months prior to enrollment
3. Willing and able to give written informed consent and comply with study procedures
4. Willing and able to participate in the study for full three months.
 
 
ExclusionCriteria 
Details  1. PSA > 4 ng/ml
2. Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy, and stent replacement) or other invasive procedures to treat BPH
3. Post-void residual volume >250mL (Transabdominal ultrasound)
4. history of Acute Urine Retention within three months before screening
5. History of confirmed malignancy or cancer of prostate or bladder or has an imminent need for surgery
6. Participants with uncontrolled Hypertension with or without medication. (BP≥ 160/100 mm of Hg)
7. Participants with uncontrolled Diabetes mellitus with or without medication (HbA1c > 8%).
8. Participants with concurrent serious cardiac dysfunction or Hepatic Dysfunction (defined as AST and/or ALT >two times of the standard upper limit) or Renal Dysfunction as serum creatinine level more than the upper limit of lab value, uncontrolled Pulmonary Dysfunction (Asthmatic and COPD patients) or any other concurrent severe disease.
9. Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study
10. Participants who are taking Ayurvedic treatment/medicine for any disease condition for the last three months
11. Participants with impaired cognition, or with a history or diagnosis of psychiatric illness and neurological disorders, etc
12. Subjects who are already taking any other medication for treatment of BPH or any related complaints
13. Use of Any other condition that PI may think can jeopardize the study.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•Changes in Lower Urinary Tract Symptoms (LUTS) & quality of life in men with benign prostatic hyperplasia by International Prostate Symptom Score (IPSS)
•Changes in prostate volume, post-void residual (PVR), Maximum flow rate, Mean flow rate
 		 03 Months
 
 
Secondary Outcome  
Outcome  TimePoints 
•Changes in laboratory parameter viz. CBC, LFT, RFT & Lipid profile   03 Months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   03/07/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Benign Prostatic Hyperplasia (BPH) is a common problem that affects the quality of life in approximately one-third of men older than 50 years. BPH is histologically evident in up to 90% of men by age 85. The primary symptom of BPH is the hesitancy of micturition, poor prolonged flow, and a sensation of incomplete emptying of the Urinary bladder; it is due to increased prostate gland volume. Alpha-adrenoceptor blockers (e.g., Alfuzocin, tamsulosin) and five alpha-reductase inhibitors are commonly used to treat LUTS attributed to BPH. They have adverse effects like dizziness, asthenia, postural hypotension, syncope, sexual dysfunction, infertility, mood disorders, gynecomastia, high‐grade prostate cancer, breast cancer, and cardiovascular morbidity/risk factors.  Prostatectomy and TURP are widely used surgical interventions in treating BPH, it also causes many complications.

Lower Urinary Tract Symptoms (LUTS) associated with BPH are also described in Ayurveda classical texts under the heading of Mutraghata. Incomplete emptying and hesitancy are the symptoms of Vatasthila, Vatakundalika, and Vatabasti; weak stream and straining are the symptoms of Mutratita, and Urgency is a symptom of Vatabasti.  

Chandraprabha vati and Gokshuradi Guggulu is very well known medicine in the management for the disease (Lower urinary tract symtoms) of mutravahastrotas. Chandraprabha vati is described for the management of Mutraghata in Yogaratnakara as well as Gokshuradi Guggulu is described for the treatment of Mutraghata in Sarangdhara Samhita.  Combination of Chandraprabha vati and Gokshuradi Guggulu is used in the management of BPH in General clinical practice.

                this is a open-labelled randomised clinical trial with active control. Sample size of the trial is 70. This study will be conducted at RARI, Jammu.

 
Close