| CTRI Number |
CTRI/2024/05/066732 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study Of ASJ Granule Against Stambhanakara Yoga Granule In Premature Ejaculation. |
|
Scientific Title of Study
|
Efficacy Of ASJ Granule Against Stambhanakara Yoga Granule In Premature Ejaculation - A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOJITRA SAGAR RASIKBHAI |
| Designation |
MD Scholar |
| Affiliation |
VPSV Ayurveda college, Kottakal |
| Address |
Department Of Kayachikitsa,
OPD NO: A102,
VPSV Ayurveda college, Kottakkal
Edarikode P.O , Malappuram, Kerala
Malappuram
KERALA
676501
India |
| Phone |
9512317452 |
| Fax |
|
| Email |
sojitrasagar42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satheesh K |
| Designation |
MD (Ay) Associate Professor |
| Affiliation |
VPSV Ayurveda college, Kottakkal |
| Address |
VPSV Ayurveda college, Kottakkal
Edarikode P.O , Malappuram, Kerala
Malappuram
KERALA
676501
India |
| Phone |
9249993257 |
| Fax |
|
| Email |
drsatheeshpdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satheesh K |
| Designation |
MD (Ay) Associate Professor |
| Affiliation |
VPSV Ayurveda college, Kottakkal |
| Address |
VPSV Ayurveda college, Kottakkal
Edarikode P.O , Malappuram, Kerala
Malappuram
KERALA
676501
India |
| Phone |
9249993257 |
| Fax |
|
| Email |
drsatheeshpdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P. S. Varier
Arya Vaidya Sala,
Kottakkal (P.O.),
Malappuram (Dist.),
Kerala - 676 503,
INDIA. |
|
|
Primary Sponsor
|
| Name |
Sojitra Sagar Rasikbhai |
| Address |
VPSV Ayurveda college,Kottakkal
Edarikode P.O, Malappuram |
| Type of Sponsor |
Other [Sojitra Sagar Rasikbhai] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aryavaidyasala Kottakkal |
Aryavaidyasala Kottakkal
Malappuram |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sojitra Sagar Rasikbhai |
VPSV Ayurveda College Hospital Kottakkal |
Department of Kayachikitsa,
OPD Room Number - A102.
Malappuram
KERALA |
9512317452
sojitrasagar42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F524||Premature ejaculation. Ayurveda Condition: SUKRAGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: ASJ granule, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Staṃbhanakara yoga Granule , Reference: CikitsÄcandṟodaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1.Those diagnosed with premature ejaculation, as per DSM-V criteria.
2.Participants aged between 21– 50 years, irrespective of race, caste, and religion.
3.Those with regular and healthy partner.
4.Those with a minimum score of 2 for performance anxiety, using the revised Singh. G et al. 2001 questionnaire.
5.Those willing to give written consent.
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed cases of diabetes mellitus, hypertension, coronary artery disease, thyroid dysfunction, renal dysfunction, and hepatic dysfunction
2.Those diagnosed with major psychiatric illness - schizophrenia, BPAD, and major depressive disorder
3.Participants with known neurological or neurodegenerative cause for sexual dysfunction
4.Those who have other sexual dysfunction
5.Those on psychiatric drugs, anti-histamines, anti-parkinsonian drugs, and anti-epileptics
6.Those with any known substance abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare The Efficacy Of ASJ Granule Against Stambhanakara Yoga Granule In The Management Of Premature Ejaculation |
Assessment will be done on 0th, 31st, 61st, 90th day of study using Sexual dysfunction assessment questionnaire (Revised G Singh et al., 2001) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the performance anxiety, sexual satisfaction, quality of life
of subjects with premature ejaculation by Golombock Rust Inventory for Sexual Satisfaction ,Sexual Quality of Life Assessment Scale For Male ,Stress questionnaire by International Stress Management Association.
|
Assessment for Sexual Satisfaction, Performance anxiety, will be done on 0th, 31st, 61st, 90th day of study And Quality of life Will be done on 0th, 61st, 90th day of study. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 3 |
|
Date of First Enrollment (India)
|
12/05/2024 |
| 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 Yet Recruiting |
| 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
|
For this study, 32 participants will be selected according to inclusion criteria. They will be randomly allocated to two groups namely the trial group and the control group with 16 participants each. the trial group participants will receive ASJ granule , 6 gm twice (morning and evening after food) daily for 60 days. The control group will be receiving stambhanakara yoga granule in same dose and duration . Assessment would be done on 0th day, 31st day, 61st day and 90th day of treatment using sexual dysfunction assessment questionnaire (Revised G Singh et al., 2001). |