| CTRI Number |
CTRI/2025/07/090934 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Uttar Basti of Kushmand Beej Taila and oral intake of Gokshuradi Guggulu in Vatastheela(BPH) |
|
Scientific Title of Study
|
Clinical evaluation of Uttar Basti of Kushmand Beej Taila and Gokshuradi Guggulu in Vatastheela |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Kumar Longia |
| Designation |
PG scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15,Department of Shalya Tantra,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405
OPD 15,Department of Shalya Tantra,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09781865068 |
| Fax |
|
| Email |
mohitlongia21@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshni Gupta |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15,Department of Shalya Tantra,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405
OPD 15,Department of Shalya Tantra,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9729070773 |
| Fax |
|
| Email |
Shimlagoa1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshni Gupta |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15,Department of Shalya Tantra,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405
OPD 15,Department of Shalya Tantra,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9729070773 |
| Fax |
|
| Email |
Shimlagoa1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Yogpeeth phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Yogpeeth phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mohit Kumar Longia |
Patanjali Ayurved Hospital |
OPD 15,Department of Shalya Tantra,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405
Hardwar
UTTARANCHAL |
09781865068
mohitlongia21@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Patanjali Ayurved Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N394||Other specified urinary incontinence. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Su. Utt. 58/27-28, Procedure details: Patient will be asked to empty his bladder and perform mild Snehana (local oleation)
with Narayan tail and Swedana (local sudation) with Dashmool kwatha for 15 minutes
over abdomen below umbilicus to mid-thigh. All the required instruments were autoclaved, and patient will be kept in supine position exposed from umbilicus to mid-thigh in a well-lit room.
Urethral meatus to achieve lubrication & anaesthesia. Under all aspetic precautions, 24ml of classically prepared lukewarm sterilised Kushmand Beej Taila wii be filled in a 50ml syringe. Its nozzle will be fixed to infant feeding tube no. 10 FR & the tube will be inserted gently into
the external meatus & oil will be pushed slowly. Care will be taken to avoid the entry of air into
the urethra. Antiseptic cleaning and draping will be done.
)
(1) Medicine Name: Kushmand Beej Taila, Reference: Su. Sutra. 45/120, Route: Urethral, Dosage Form: Taila, Dose: 24(ml), Frequency: od, Duration: 12 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Guggulu, Reference: Sharangdhar Samhita Madhyama Khand Chapter 7 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -Half an hour after meal |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed cases of BPH along with lower urinary tract symptoms.
Age group between 40 -80 years age.
Grade 1 and 2 Prostate enlargement.
Controlled Hypertension and Diabetes Mellitus
|
|
| ExclusionCriteria |
| Details |
Diagnosed case of :-
1.Serology positive
2.Stricture Urethra
3.Prostate carcinoma
4.Idiopathic bladder neck obstruction
5.Chronic Renal failure
6.Prostate calculi
7.Neurogenic bladder
8.K/C/O Cardiac disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)International Prostate Symptoms Score (IPSS) |
0, 3, 7, 12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
) Serum PSA (prostate specific antigen) test.
2) Ultrasonography (USG) of abdomen and pelvis pre and post void
3) Urine (Routine and Microscopic)
4) USG KUB (if needed) |
0, 12 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/08/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 this trial we are selecting patients of Vatastheela (Benign Prostatic Hyperplasia) Uttar Basti of Kushmand Beeja Taila with Gokshuradi Guggulu orally will be given to the patients and then conclusion will be made on the basis of observation, which will be done on subjective and objective parameters. |