| CTRI Number |
CTRI/2021/07/034911 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of Ayurvedic Panchakarma Basti therapy in male sexual dysfunction |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the efficacy of Matra Basti, Uttar Basti and Taila Pana in the management of Klaibya with special reference 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 |
Dr Anil Patidar |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG dept of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8233193382 |
| Fax |
|
| Email |
patelanil143.pp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG dept of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG dept of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute Of Ayurveda Jorawar Singh Gate Amer Road Jaipur |
| 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 |
| Dr Anil Patidar |
National institute of Ayurveda |
OPD NO 2 and IPD of Panchakarma Dept National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN |
8233193382
patelanil143.pp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N529||Male erectile dysfunction, unspecified. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ashwagandha Taila orally |
In this group Ashwagandha Taila orally will be given 10 ml, twice a day with milk as Anupana for 16 days. |
| Intervention |
Matra Basti with Ashwagandha Taila |
Matra Basti with Ashwagandha Taila will be administered, 70ml/day for 16 days. |
| Comparator Agent |
Uttar Basti with Ashwagandha Taila |
Uttar Basti with Ashwagandha Taila will be administered, 20ml/day for 3 consecutive days followed by gap of 3 days. Process will be continued for 3 sitting. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1 Age : 25 to 60 years
2 Gender : Male
3 Patients presenting with Samanya Lakshana of Klaibya (Erectile Dysfunction).
4 Unable to perform the sexual act due to lack of erection, lack of rigidity at least 50% of coital instances.
5 Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1 Penile anatomical defect.
2 Spinal cord injury.
3 Major organic or psychosomatic disorder.
4 Poorly controlled Diabetes mellitus, severe systemic diseases, uncontrolled hypertension.
5 ED due to surgery of colon, prostate, bladder or rectum.
6 Carcinoma of penis.
7 Hypo/Epispadias.
8 Phimosis.
9 Patients with history of alcohol, chain smokers or drug abuse.
10 Patients with Venereal disease, HIV.
11 Congenital defect of genital organ.
12 Natural impotency.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IIEF-15 International Index of Erectile Function |
0 16 and 31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lingashaithilyata, Mlanashishnata |
0 16 and 31 Days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/07/2021 |
| 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="1"
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
|
After the complete
examination and investigation, all 30 patients of Klaibya (ED) will be divided randomly into three groups - Group A- Matra Basti with Ashwagandha Taila will be administered, 70ml/day for
16 days. Group B- Uttar Basti with Ashwagandha Taila
will be administered, 20ml/day for 3 consecutive days followed by gap of 3 days.
Process will be continued for 3 sitting. Group C- In this
group Ashwagandha Taila orally will be given 10 ml, twice a day with milk as Anupana for 16 days. FOLLOW UP-Assessment
will be done on the day of enrollment, completion of treatment and on follow up
after 15 days.
|