| CTRI Number |
CTRI/2024/09/074481 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the effect of Trikatvadi gudika along with Gokshura kashaya in the treatment of BPH ( Benign Prostatic Hyperplasia)
|
|
Scientific Title of Study
|
Effect of Trikatvadi gudika along with Gokshura
kwatha in the management of 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 Aswathy Krishnan |
| Designation |
Second Year PG Scholar |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Salyatantra
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8138991249 |
| Fax |
|
| Email |
aswathykrishnan161@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa M S |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Salyatantra
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9495437525 |
| Fax |
|
| Email |
drdeepams2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswathy Krishnan |
| Designation |
Second Year PG Scholar |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Salyatantra
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8138991249 |
| Fax |
|
| Email |
aswathykrishnan161@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Aswathy Krishnan |
| Address |
P G Scholar
Department of Salyatantra
Government Ayurveda college Thiruvananthapuram
695001
Kerala
India
|
| Type of Sponsor |
Other [Self] |
|
|
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 Aswathy Krishnan |
Government Ayurveda College Thiruvananthapuram |
Department of salyatantra
Op Division
Room No 3
Thiruvananthapuram
Thiruvananthapuram
KERALA |
8138991249
aswathykrishnan161@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda College Thiruvananthapuram |
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: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TRIKATVADI GUDIKA, Reference: BHAVAPRAKASHA MADHYA KHANDA CHAPTER 35, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -6 ml honey), Additional Information: -(2) Medicine Name: GOKSHURA KWATHA , Reference: BHAVAPRAKASHA MADHYA KHANDA CHAPTER 35, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 1.5 G TRIKATVADI GUDIKA MIXED WITH 6 ML OF HONEY AND TAKEN ALONG WITH 48 ML GOKSHURA KWATHA AT MORNING AND EVENING BEFORE FOOD |
|
|
|
Inclusion Criteria
|
| Age From |
41.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Participants with signs and symptoms of BPH diagnosis confirmed by USG
Volume of prostate gland within 25 to 60 ml
Residual urine within 50 to 100 ml
Participants with PSA level less than 4 ng/ml |
|
| ExclusionCriteria |
| Details |
Known case of Bladder neck stenosis and urethral stricture
Known case of Prostate cancer
Catheterized persons
Known cases of systemic diseases like Tuberculosis, Hepatitis B, HIV, Cardiac diseases and
Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reducing the symptoms of BPH ( International prostate symptom score )
Reducing the size of prostate gland and post void residual urine ( USG ) |
Subjective assessment will be done on 0th day, 15th day and 30th day.
Objective assessment will be done on 0th day and 30th day.
During follow up period subjective assessment will be done on 45th day and 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The above study deals with assessing the effect of Trikatvadi gudika along with Gokshura kwatha in the management of Benign Prostatic Hyperplasia. Evaluation is made on reducing the symptoms , size of prostate gland and post void residual urine . The symptoms are assessed through International Prostate Symptom Score (IPSS) and the size of prostate gland and post void residual urine are assessed through USG . |