| CTRI Number |
CTRI/2025/09/095274 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative open clinical trial on effect of uttar basti and madhutailik basti along with vraddha dand churna in the management of klaibya w.s.r. to erectile dysfunction |
|
Scientific Title of Study
|
A comparative open clinical trial on effect of uttar basti and madhutailik basti along with vraddha dand churna in the management of klaibya w.s.r. to erectile dysfunction: a randomized controlled trial |
| 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 shubham nargave |
| Designation |
Post graduation scholar |
| Affiliation |
Govt dhanwantari ayurvedic medical college and hospital ujjain mp |
| Address |
Panchakarma department govt dhanwantari ayurvedic medical college and hospital ujjain mp
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
8109487385 |
| Fax |
|
| Email |
shubhamnargave111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr j p chaurasia |
| Designation |
Principal and hod |
| Affiliation |
Govt dhanwantari ayurvedic medical college and hospital ujjain mp |
| Address |
Panchakarma department govt dhanwantari ayurvedic medical college and hospital ujjain mp
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9893169434 |
| Fax |
|
| Email |
cjagesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr j p chaurasia |
| Designation |
Principal and hod |
| Affiliation |
Govt dhanwantari ayurvedic medical college and hospital ujjain mp |
| Address |
Panchakarma department govt dhanwantari ayurvedic medical college and hospital ujjain mp
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9893169434 |
| Fax |
|
| Email |
cjagesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt dhanwantari ayurvedic medical college and hospital ujjain mp |
|
|
Primary Sponsor
|
| Name |
Govt dhanwantari ayurvedic medical college and hospital ujjain mp |
| Address |
Chimanganj mandi ujjain madhya pradesh india pincode 456006 |
| 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 shubham nargave |
Govt dhanwantari ayurvedic medical college and hospital ujjain mp |
opd no 22 panchakarma department chimanganj mandi agar road ujjain mp india pin code 456006
Ujjain
MADHYA PRADESH |
8109487385
shubhamnargave111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee govt dhanwantari ayurvedic college ujjain |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N529||Male erectile dysfunction, unspecified. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Sushrut Chikitsa 37, Procedure details: Poorva Karma- Evacuation of the bladder & bowels. Abhyanga: By any Vatashamak Tail. Abhyanga should be given for ten minutes on the Kati Pradesha, Adhodara, Prustha and Parshva Pradesha. Sweden: After Abhyanga, Swedana will be given to same parts for about 15 minutes with hot water bag. Examination of pulse, B.P. will be done. Patient will be placed in supine position. The genital organs will be painted with antiseptic solution and will be covered with surgical towel. all equipment will be sterlized like syringe, catheter, medicated oil etc. Pradhan Karma - Utilize basti yantra containing medicated oil and lubricate basti yantra and uretral meatus with sneha. we will Carefully insert netra into urethra. Push the oil slowly. while withdrawing netra, we will leave some oil in the putaka. Paschat Karma- Patient will be advised to rest for some time post uttar basti. Pulse and Blood pressure recorded will be for one hour. Evening diet after uttar basti pratyagaman (Mansarasa, Milk, Yush) will be advised. Oral medicine- Vraddha Dand Churna 5 gm will be given twice a day. )
(1) Medicine Name: Ksheerbala taila, Reference: Dr.K. Nishteswar & Dr. R. Vidyanath, Sahasrayogam. chapter 18 (Taila yoga Prakaranam), Route: Urethral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Patients with signs and symptoms of Erectile dysfunction according the special scoring
system for sexual parameters. Patients those fit for both Basti Karma(Uttar Basti & Madhutailik Basti).Patients who have given written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patient’s age below 21 years and above 50 years. Patients having other systemic pathology like Tuberculosis, Renal failure, Diabetes
Mellitus, Hypertension, severe urinary tract infections, Nephrolithiasis, ischemic heart
disease Urethral stricture and Renal Diseases or malignancy of urogenital system etc. Patients having congenital deformity of urogenital tract. Patients who are not willing to sign written consent to participate in the study.Accidental injury of genital organ. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
it is expected that at the end of the study we would be able to demonstrate the effect of uttara basti and madhutailik basti along with vraddha dand churna in the management of
erectile dysfunction. it is further expected that this study would be able to provide efficacy of uttara basti and madhutailik basti along with vraddha dand churna management of erectile dysfunction. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| 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="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is the randomized clinical study of Uttar Basti and Madhutailik Basti along with Vraddha dand churna in the management of Klaibya w.s.r. to Erectile dysfunction. All the 40 patients of male sex randomly selected will be divided into 2 groups on the basis of computer generated randomized group A containing 20 patients will be given Uttar Basti and Vraddha dabd churna and group B 20 patients given Madhutailik Basti and Vraddha dabd churna follow up will be on 15th day and 45th day. |