| CTRI Number |
CTRI/2017/11/010671 [Registered on: 28/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
31/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Ayurvedic management of klaibya(erectile dysfunction) with oil made from kaucha beej(Mucuna pruriens) |
|
Scientific Title of Study
|
"A clinico-comparative study of Uttarbasti and Shamanasenha in the management of klaibya w.s.r. to erectile dysfunction
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
jigar mansukhlal narsana |
| Designation |
md scholar |
| Affiliation |
Govt akhandanand ayurved |
| Address |
Govt akhandanand ayurved college bhadra room no 11 panchkarma departent
Ahmadabad
GUJARAT
380001
India |
| Phone |
9067145188 |
| Fax |
09067145188 |
| Email |
vd.jigarnarsana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
drfalgun patel |
| Designation |
assistant proffesor |
| Affiliation |
Govt akhandanand ayurved |
| Address |
Govt akhandanand ayurved
college bhadra room no 11 panchkarma department
Ahmadabad
GUJARAT
380001
India |
| Phone |
9426404004 |
| Fax |
|
| Email |
vd.falgun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
jigar mansukhlal narsana |
| Designation |
md scholar |
| Affiliation |
Govt akhandanand ayurved |
| Address |
Govt akhandanand ayurved
college bhadra room no 11 panchkarma department
Ahmadabad
GUJARAT
380001
India |
| Phone |
9067145188 |
| Fax |
|
| Email |
vd.jigarnarsana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt akhandanand ayurved college bhadra ahmedabad |
|
|
Primary Sponsor
|
| Name |
Govt akhandanand ayurved college |
| Address |
Govt akhandanand ayurved college bhadra ahmedabad |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| jigar mansukhlal narsana |
Govt akhandanand ayurved college |
Room no 11 panchkarma department govt akhandanand ayurved college bhadra
Ahmadabad
GUJARAT |
9067145188
vd.jigarnarsana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients Suffering from klaibya(erectile dysfunction), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A clinical study of Shamana sneha in the management of klaibya |
15 patients will be taken in group B and in this Shaman Sneha will be Given daily at annakaleprakanshite (At lunch time)
dose 20ml sneha
with 200 ml hot cow milk & 5gm sharkara
total duration 4 weeks |
| Intervention |
A clinical study of uttar basti in the management of klaibya |
15 patients will be taken in group A and in this Uttarbasti will be given for continue 3 days with 4 days gap.
dose 20 ml
the cycle repeat for more 3 times.
total 4 times (total 12 Uttarbasti)
time of administration:
(12-3 at noon, after meal)
total duration 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. A person having classical symptoms of Klaibya and as well as Erectile dysfunction.
15 patients will be taken in GROUP A and In this Uttarbasti will be given for continue 3 days with 4 days gap.
Dose 20 ml
The cycle repeat for more 3 times.
Total 4 times (total 12 Uttarbasti)
Time of administration:
(12-3 at noon, after meal)
Total duration 4weeks.
15 patients will be taken in GROUP B and In this Shaman Sneha will be Given daily at Annakaleprakanshite (At Lunch time)
Dose 20ml Sneha
With 200 ml hot cow milk & 5gm Sharkara
Total duration 4weeks
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Results will be assessed on the basis of relief in the signs and symptoms of klaibya |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Results will be assessed on the basis of relief in the signs and symptoms of klaibya |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
29/05/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
To study the clinico comparative effect of uttar basti and shaman sneha in the managemnt of klaibya. This study is randomised, patients is blinded,parallel group trail.Uttar basti will be given as per s.o.p..Shaman sneha will be given at annakalprakankshite as per texts. |