Treatment of Premature ejaculation (Early ejaculation of semen) with Unani medicine Majoon-e-Ispand

Phase 3

Not yet recruiting

• Conditions: Unspecified male sexual dysfunction,

• Registration Number: CTRI/2019/02/017820
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM

Brief Summary

This study is designed as a multicentric open trial in patients with **SurÊ»a al-InzÄl (Premature Ejaculation).** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed at every week.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. 

**Composition of *Majoon-e-Ispand Sokhtani***

| | | | | |

| --- | --- | --- | --- | --- |

|**S.No.**

**Ingredients**

**Botanical / Chemical name**

**Part used**

**Quantity**

|1.

Ispand Sokhtani

*Peganum harmala* L.

Seeds

30 g

|2.

Bisbasa

*Myristicafragrans*H.

Aril/Seed covering

30 g

|3.

Jauzbawa

*Myristicafragrans* H.

Seed

30 g

|4.

Qaranfal

*Syzygiumaromaticum* L.

Flower buds

30 g

|5.

Darchini

*Cinnamomum zeylanicum* B.

Bark

30 g

|6.

Kunjad Siyah Muqashshar

*Sesamum indicum* L.

Seeds

40 g

|7.

Asal / Qandsafaid

Honey / Sugar

 600 g

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-03
• Last Update Posted: 2020-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

The following criteria will be strictly followed for inclusion of cases in the study: 1.Men in the age group of 21-65 years 2.Men with a PEDT score > 11 3.Men with lifelong /Acquired PE meeting the evidence-based definition proposed by ISSM: LPE IELT ≤1 min from the first sexual experience Inability to delay ejaculation Related negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy APE A clinically significant reduction in IELT, often ≤3 min Lacking the ability to delay ejaculation Related negative personal consequences as similar with that of LPE.

Exclusion Criteria

The patients of SurÊ»a al-InzÄl (Premature ejaculation) with following conditions will be excluded from the study: 1.Patients with Erectile dysfunction 2.Major psychiatric disorders or cognitive impairments 3.Patients with history of intake of any drug causing sexual dysfunction and affecting psychological status 4.History of addiction (alcohol, drug abuse) 5.Patients with chronic diseases, requiring long term treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in sign and symptoms of SurÊ»a al-InzÄl (Premature Ejaculation)	2 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment.	Investigations will be done at baseline and end of treatment

Trial Locations

Locations (2)

Clinical Research Unit (CRU); 🇮🇳 Nimar, MADHYA PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM); 🇮🇳 Bhadrak, ORISSA, India

Clinical Research Unit (CRU)

🇮🇳Nimar, MADHYA PRADESH, India

Dr M A Waheed

Principal investigator

9347351749

mawaheed313@gmail.com

Hkm Mujahid Sami

Principal investigator

9425415145

cruburhanpur@rediffmail.com