| CTRI Number |
CTRI/2023/07/054658 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
17/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of Ksharapippali and Mahodarahara Kashaya in Vatashteela w.s.r to BPH |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Ksharapippali and Mahodarahara kashaya in Vatashteela with special reference to Benign Prostatic Hyperplasia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akruthi S Gowda |
| Designation |
PG Scholar |
| Affiliation |
Sri Jayachamarajendra Government Ayurveda and Unani Hospital Bengaluru |
| Address |
Government Ayurvedic Medical College and Hospital
Dhanwantari road
Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
8548086179 |
| Fax |
|
| Email |
akruthisgowda1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Srinivas Masalekar |
| Designation |
Professor and HOD |
| Affiliation |
Sri Jayachamarajendra Government Ayurveda and Unani Hospital Bengaluru |
| Address |
Government Ayurvedic Medical College and Hospital
Dhanwantari road
Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
9886632966 |
| Fax |
|
| Email |
masalekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivas Masalekar |
| Designation |
Professor and HOD |
| Affiliation |
Sri Jayachamarajendra Government Ayurveda and Unani Hospital Bengaluru |
| Address |
Government Ayurvedic Medical College and Hospital
Dhanwantari road
Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
9886632966 |
| Fax |
|
| Email |
masalekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra OPD
Government Ayurvedic Medical College
Dhanvantari road
Majestic
Bengaluru 560009 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR AKRUTHI S GOWDA |
Government Ayurvedic Medical College Bengaluru |
Shalyatantra OPD
Government Ayurvedic Medical College
Majestic
Bengaluru 560009
Bangalore
KARNATAKA |
8548086179
akruthisgowda1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT AYURVEDIC MEDICAL COLLEGE BENGALURU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KSHARAPIPPALI, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Go Ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: MAHODARAHARA KASHAYA, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1.Subject with signs and symptoms of Vatashteela (BPH).
2.Subject with mild to moderate BPH with score 1-19, as per The International Prostate Symptom
Score index. |
|
| ExclusionCriteria |
| Details |
1.Subject with malignancy.
2.Subject more than 80 years of age.
3.Subject with severe cardio vascular, Renal or Hepatic disorders, uncontrolled Hypertension &
Diabetes mellitus.
4.Subjects with immune compromised diseases.
5.Subject with USG findings suggestive of severe Hydroureteronephrosis.
6.Post-void Residual urine volume more than 100ml as assessed by USG of Abdomen and pelvis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in lower urinary tract symptoms |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in post void residual urine volume & reduction in enlargement of prostate |
28 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 |
|
Date of First Enrollment (India)
|
30/07/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study named a comparative clinical study to evaluate the efficacy of Ksharapippali and Mahodarahara kashaya in Vatashteela with special reference to Benign Prostatic Hyperplasia that will be conducted in Government Ayurvedic Medical College and Hospital Bengaluru Karnataka. |