| CTRI Number |
CTRI/2024/06/069188 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Usheeradi Taila Uttar Basti and Hingwadi Gutika in Vatashtheela ( Enlargement of Prostate Gland) |
|
Scientific Title of Study
|
Clinical Study on the role of Hingwadi Gutika and Usheeradi
Taila Uttar basti in Vatashtheela ( 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 Sandeep Kumar Jakhar |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur,Rajastan |
| Address |
PG Department Of shalya tantra Post Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8824887724 |
| Fax |
|
| Email |
sandeepjakhar540@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar Jakhar |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur,Rajastan |
| Address |
PG Department Of shalya tantra Post Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8824887724 |
| Fax |
|
| Email |
sandeepjakhar540@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Kumar Gupta |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur,Rajastan |
| Address |
PG Department Of shalya tantra Post Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Ayurved Jodhpur Rajasthan India 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Ayurved Jodhpur,Rajastan |
| Address |
PG Department Of shalya tantra Post Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
342037
India |
| Type of Sponsor |
Government medical college |
|
|
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 Sandeep Kumar Jakhar |
Sanjeevani hospital Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
PG Department Of shalya tantra Post Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
342037
India
Jodhpur
RAJASTHAN |
8824887724
sandeepjakhar540@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurved Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N400||Benign prostatic hyperplasia without lower urinary tract symptoms. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: sushruta chikitsa sthana 37 , Procedure details: Bastidana procedure from the refrence shushruta samhita will be followed under complete aseptic condition for the proposed study as patient will be made to sit on the stool up to hight of knee
Head of the urinary bladder of patient will be washed thoroughly and ghritayukta shalaka will be introduced gently in the penis and urethra in order to check the presence of any obstruction . then bastinetra smeared with ghrita introduced slowly 6 angula in gently in the penis and urethra respectively according to the direction of perineal suture Bastiputaka filled with usheeradi Taila will be attached with the another opening of the basti netra)
(1) Medicine Name: Usheeradi taila, Reference: Bhaisajya ratnavali 35, Route: Urethral, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 28 Days(2) Medicine Name: Hingwadi gutika, Reference: Sharangdhar samhita madhyam khand , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 12(g), Frequency: tds, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Patients with classical sign and symptoms of vatastheela |
|
| ExclusionCriteria |
| Details |
1 Patient with acute retention
2 Malignant condition of uro genital system
3 Diabetes mellitus
4 Renal failure and other malignancy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the efficacy of basti chikitsa and hingwadi gutika in BPH(vatastheela) |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve general health of patient |
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
Months="10"
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
|
Number of patients: 40 patients Type of study - open labelled, Randomised clinical study Procedure - 40ml Usheeradi taila uttarbasti is given with oral intake of Hingwadi gutika 12 g tds Duration of study- 28 days Follow up - every seven days
|