A Survey and Clinical Study of Ayurvedic formulations and Psycho-therapy in the management of Manas Klaibya (Psychological impotence) in Male Participants�
Phase 2
- Conditions
- Health Condition 1: N521- Erectile dysfunction due to diseases classified elsewhere
- Registration Number
- CTRI/2022/09/045610
- Lead Sponsor
- ational Institute of Ayurveda Deemed to be University Denovo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients suffer with classical sign and symptoms of Manas Klaibya (Psychological
impotence).
2. Patients having scoring less than 21 with International Index of Erectile Dysfunction
(IIEF-5) questionnaire (SHIM).
3. Patients willing to give written informed consent
Exclusion Criteria
1. Patients having other history of systemic pathology like Tuberculosis, Renal failure,
Diabetes Mellitus, Hypertension, severe urinary tract infections, Urethral stricture and
malignancy of urogenital system etc.
2. Patients having congenital deformity of urogenital tract and structural abnormalities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To understanding the etiopathogenesis and evaluate the efficacy of Guduchyadi Rasayana, <br/ ><br>Vidarikanda Churna and Sattvavajaya Chikitsa (Psycho-therapy) in Manas Klaibya <br/ ><br>(Psychological impotence) of male participants. <br/ ><br>Timepoint: 60 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. To assess changes in Serum Testosterone (Total) level before and after Intervention b/w <br/ ><br>day 0 and day 60. <br/ ><br>2. To assess changes in International Index of Erectile Function (IIEF-5) Score before and <br/ ><br>after intervention i.e b/w day 0 and day 60. <br/ ><br>3. To assess the changes in Sexual Quality Of Life Questionnaire (SQLQ) before and after <br/ ><br>intervention i.e b/w day 0 and day 60Timepoint: 60 Days.