| 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
|
|
|
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
|
|
|
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 | - | 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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