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CTRI Number  CTRI/2025/06/088730 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 09/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Treatment of having trouble getting or keeping an erection firm enough for sexual activity using Ayurvedic treatment 
Scientific Title of Study   An open label single arm clinical study to evaluate the combined efficiency of Madhutailika basti and Kamini vidravana rasa in the management of Klaibya vis a vis Erectile dysfunction 
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 Siddalinga swamy J M 
Designation  PG SCHOLOR 
Affiliation  Government Ayurveda Medical College ,Mysuru 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysuru Vishweshwaraiah circle Devraja Mohalla Mysuru Karnataka 570001 India Mysore KARNATAKA 570001 India

Mysore
KARNATAKA
570001
India 
Phone  7348914705  
Fax    
Email  drsiddumathad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Kumar M D 
Designation  Professor 
Affiliation  Government Ayurveda Medical College ,Mysuru 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysuru Vishweshwaraiah circle Devraja Mohalla Mysuru Karnataka 570001 India Mysore KARNATAKA 570001 India

Mysore
KARNATAKA
570001
India 
Phone  9986083244  
Fax    
Email  drsanjaygowda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Siddalinga swamy J M 
Designation  PG SCHOLOR 
Affiliation  Government Ayurveda Medical College ,Mysuru 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysuru Vishweshwaraiah circle Devraja Mohalla Mysuru Karnataka 570001 India Mysore KARNATAKA 570001 India

Mysore
KARNATAKA
570001
India 
Phone  7348914705  
Fax    
Email  drsiddumathad@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital Mysuru Vishweshwaraiah circle Devraja Mohalla Mysore KARNATAKA 570001 India 
 
Primary Sponsor  
Name  DR SIDDALINGA SWAMY J M 
Address  Government Ayurveda Medical College and Hospital Mysuru Vishweshwaraiah circle Devraja Mohalla Mysore KARNATAKA 570001 India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Siddalinga swamy J M  Government Ayurveda Medical college Mysuru  kayachikitsa opd number 10,New sayyaji rao road near vishweshwaraya circle, mandi mohalla Mysuru Karnataka 570001
Mysore
KARNATAKA 
7348914705

drsiddumathad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Governement Ayurveda medical college ethical clearance committee Mysuru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N529||Male erectile dysfunction, unspecified. Ayurveda Condition: KLAIBYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAdhutailikabastiH, माधुतैलिकबस्तिः (Procedure Reference: Charaka Samhitha Siddhisthana 12th chapter 18th shloka, Procedure details: total duration- 08 days 1 Basti per day)
(1) Medicine Name: Kaminividravana rasa, Reference: Rasayogasagara 819th shloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 125(mg), Frequency: od, Duration: 35 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  59.00 Year(s)
Gender  Male 
Details  Both fresh cases and treated cases will be included.
The definition of fresh cases includes freshly diagnosed and untreated cases of ED.
The definition of treated cases includes already diagnosed and treated cases of ED who had voluntarily discontinued the treatment with a flush-out period of 7 days.  
 
ExclusionCriteria 
Details 
• Subjects with systemic and structural deformities such as Cryptochidism, Varicoceal grade 3, and
Peyronie’s disease, will be excluded.
• Post-traumatic ED will be excluded.
• Subjects suffering from sexually transmitted disease (STD), Human immunodeficiency virus
(HIV), Hepatitis C virus (HCV), and Tuberculosis (TB) will be excluded.
• Subjects with uncontrolled Diabetes mellitus i.e. FBS more than 200mg per dL and PPBS more than 250 mg per dL will be
excluded.
• Subjects with Stage 2 Hypertension (more than 160 by 100) will be excluded.
• Chronic Alcoholism will be excluded.
• Major psychiatric illness associated with ED will be excluded.
• ED more than 10 years will be excluded.
• Subjects who are unfit for Basti will be excluded.
• Subjects with other systemic disorders that interfere with the intervention will be excluded.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increases in the scoring of IIEF.  0th day, 46th day 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in the grading   45 days 
 
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 4 
Date of First Enrollment (India)   30/06/2025 
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)   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  
Erectile dysfunction (ED) is the failure to achieve erection, ejaculation, or both. It affects 10-25% of middle-aged and elderly men. ED may result from three basic mechanisms: failure to initiate (psychogenic, endocrinologic, or neurogenic); failure to fill (arteriogenic); and failure to store adequate blood volume within the lacunar network (vasculogenic dysfunction). ED is the most common burning issue in males, recent hospital-based study from Southern India has reported the prevalences of ED and Premature ejaculation to be 48% and 43%, respectively. ED is a major cause of Impotency. In Western medical science, the management of ED includes oral medication Phosphodiesterase (PDE) 5 inhibitors (sildenafil, Tadalafil), Testosterone replacement, Androgen therapy, Intra urethral alprostadil, and intra cavernosal injection. These hormonal therapies have their own complications such as patients may experience Nausea, Bradycardia, Gastric irritation, and Bloating of the guts. Prolonged usage of such medications leads to Gynecomastia, Obscured vision, photophobia, stomach and pelvic pain, Benign Prostatic Hyperplasia, and Prostatic cancer. These treatment modalities have limitations, not feasible, time-consuming, expensive, are not patient-friendly. The absence of sexual function hampers marital relationships and sometimes ends in divorce. Thus there is a need to develop an elective and viable management to overcome the burning issue in the present day. Klaibya / kleebata which is mentioned under Shukravaha srotovikara in Ayurveda can be co related to Erectile dysfunction. Klaibya is defined as “Klaibyam Ithi Dvajanucharyam”, the condition in which lack of erection/absence of erection is due to distinct etiological factors. Ayurveda opines that the pathophysiology of klaibya is mainly due to Shukravaha srotodusti and Vatadosha, among these Charaka Samhita specifies the involvement of Vyana and Apana vayu. To get over this condition, and for vitiated vatadosha, Basti5 is the best line of treatment. hence they basically concentrate on Madhutailika basti6 as prime Vrishya basti, because it has properties like Vyapadam cha api asambhavaha and no specific parihara Vishaya should be followed. Kamini vidravana rasa is one such Rasoushadi said to be a vrishya. It is a Herbo-mineral medicine and has aphrodisiac properties that play an important role in the management of ED. It has the potential to improve sexual performance by improving stamina, Vigor, hardness of organ, and delaying the time of ejaculation. The study intends to evaluate the combined effect of Madhutailika basti and kaminin vidravana rasa. 











 
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