Health Condition 1: null- Premature ejaculation
Conditions
Interventions
Intervention1: Nagavallyadi churna: Nagavalli, Bala, Jati, Jatiphala, Paribhadra, Apamarga, Ashwagandha, kankola, Ushira, Yastimadhu and Vacha
Control Intervention1: Placebo: Starch
Sponsors
Rajiv Gandhi University of Health Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects aged >=18 years 2. Subject has to provided written informed consent(Annexure-4 ) 3. Subjects must be in a stable, monogamous, sexual relationship with the same partner for at least 6 months and plan to maintain this relationship for the duration of the trial. 4. Subjects with the same sexual orientation and partner gender Preference. 5. Acceptance to attempt intercourse on a regular basis and at least once a week. 6. Non-pregnant partners. 7. Subjects must be in good general health with no clinically relevant abnormalities, normal blood chemistry, testosterone, CBC, urinalysis, and 12-lead ECG 8. Subjects must meet criteria for diagnosis of PE using a multivariate definition of PE and a baseline trial specific threshold ejaculatory latency time, e.g., intravaginal ejaculatory latency time (IELT). 9. Subjects must meet criteria for diagnosis of PE with a PEDT score >=11 indicates
Exclusion criteria
Exclusion criteria: 1. Use of any investigational drug within the past month or within a period of five times the drug half-life, if it is longer. 2. Any significant somatic disorder. 3. Any potential neurologic, urologic, or endocrine cause of PE. 4. Any current or previous psychiatric disorder. 5. Current or previous alcohol or psychoactive substance abuse or dependence. 6. Use of any medication that could cause sexual dysfunction. 7. Any other sexual dysfunction including ED. 8. Untreated hypogonadism, hyperprolactinemia, or hyper- or hypothyroidism. 9. Clinically significant sexual dysfunction of the partner. 10. Subject with hypoactive sexual desire, retrograde, delayed or absent orgasm or ejaculation or ED (IIEF-5 >21) (Annexure -1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the efficacy of Nagvalyadi Churna with respect to duration of IELT safety and tolerability change in IPETimepoint: safety and tolerability change in IPE will be assessed in every week of treatment phase | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability change in IPETimepoint: safety and tolerability and change in IPE will be assessed in every week of treatment phase | — |
Countries
India
Contacts
Public ContactDr Venkatesha S
JSS Ayurveda Medical College and Hospital
Outcome results
None listed