FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/11/037965 [Registered on: 11/11/2021] Trial Registered Prospectively
Last Modified On: 10/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Solution Focused Brief Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to assess the effect of Solution Focused Brief Therapy along with an ayurvedic formulation, Sthambhanakara yoga in patients with premature ejaculation 
Scientific Title of Study   Add on effect of Solution Focused Brief Therapy with Stambhanakara Yoga in Premature ejaculation - A Randomized Open Label Comparative clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreeram P U 
Designation  MD Scholar 
Affiliation  Vaidyaratnam P S Varier Ayurveda College Kottakkal 
Address  Manovigyan Avum Manasroga Department of Kayachikitsa Vaidyaratnam P S Varier Ayurveda College Kottakkal Edarikode Malappuram

Malappuram
KERALA
676501
India 
Phone  8086376346  
Fax    
Email  drsreeramayur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jithesh M 
Designation  Guide 
Affiliation  Vaidyaratnam P S Varier Ayurveda College Kottakkal 
Address  Manovigyan Avum Manasroga Department of Kayachikitsa Vaidyaratnam P S Varier Ayurveda College Kottakkal Edarikode Malappuram

Malappuram
KERALA
676501
India 
Phone  9447882885  
Fax    
Email  drjitheshm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jithesh M 
Designation  Guide 
Affiliation  Vaidyaratnam P S Varier Ayurveda College Kottakkal 
Address  Manovigyan Avum Manasroga Department of Kayachikitsa Vaidyaratnam P S Varier Ayurveda College Kottakkal Edarikode Malappuram

Malappuram
KERALA
676501
India 
Phone  9447882885  
Fax    
Email  drjitheshm@gmail.com  
 
Source of Monetary or Material Support  
Vaidyaratnam P S Varier Ayurveda College Kottakkal 
 
Primary Sponsor  
Name  SREERAM P U 
Address  Manovigyan Avum Manasroga Department of Kayachikitsa Vaidyaratnam P S Varier Ayurveda College Kottakkal Edarikode Malappuram 
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 
Sreeram P U  Vaidyaratnam P S Varier Ayurveda College Hospital  Vaidyaratnam P S Varier Ayurveda College Kottakkal Edarikode Malappuram
Malappuram
KERALA 		 8086376346

drsreeramayur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board Vaidyaratnam P S Ayurveda College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F524||Premature ejaculation. Ayurveda Condition: shukragata vAta,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Stambhanakarayoga, Reference: Chikitsachandrodaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: Solution Focused Brief Therapy Sessions will be administered during initial 4 weeks in frequency, 1 session per week, each session having 45 minutes duration
2Comparator ArmDrugClassical(1) Medicine Name: Stambhanakarayoga, Reference: Chikitsachandrodaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information:
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  Those diagnosed as having premature ejaculation, as per DSM – V criteria.
Those with a regular and healthy partner.
Those with a minimum score of 2 for performance anxiety, using revised Singh. G et al.
2001 questionnaire.
Those willing to provide written consent.
 
 
ExclusionCriteria 
Details  Participants with a known organic cause for sexual dysfunction.
Known case of diabetes mellitus, hypertension, coronary artery disease, thyroid dysfunction, renal dysfunction, hepatic dysfunction.
Those with any major psychiatric illness.
Those on anti-histamines, anti-parkinsonian drugs, anti-epileptics, NSAIDs.
Those with any known substance abuse. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Intra Ejaculatory Latency Time and Performance anxiety  Three Months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Performance anxiety with revised Singh G et al. 2001 questionnaire less than 2 score  Three Months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   22/11/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Premature (early) ejaculation (PE) is considered to be the most common sexual disorder in men and is a poorly understood condition. In ayurvedic literature, the condition of premature ejaculation resembles Åšukṟagata vāta mentioned in gatatva conditions of vāta. Recent advances in the area of premature ejaculation reveal that psychological interventions along with appropriate medicines enhance the quality of sexual life in dysfunctional couples. Staṃbhanakara yoga is a unique formulation mentioned in the Ayurvedic textbook Cikitsācandṟodaya and is indicated in improving the virility of men. Vṟiá¹£ya, Balya and Åšukṟastaṃbhaka action of this formulation has been studied previously and it also shows significant results in premature ejaculation. The null hypothesis of the protocol is Solution Focused Brief Therapy with 12 gm of Staṃbhanakara yoga is equally or less effective than Staṃbhanakara yoga alone in premature ejaculation. The primary objective is to compare the add on effect of Solution Focused Brief Therapy with Staṃbhanakara yoga, against Staṃbhanakara yoga in premature ejaculation. 
Close