| CTRI Number |
CTRI/2024/07/070748 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management Of Klaibya With Special Reference To Erectile Dysfunction |
|
Scientific Title of Study
|
An open label clinical trial to evaluate the efficacy of Vidangaadya Taila Uttar Basti and Pramehamihir Taila Upastha Basti followed by Amritprasha Ghrita in the management of Klaibya with special reference to Erectile Dysfunction |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek ranjan jha |
| Designation |
Pg scholar |
| Affiliation |
National institute of ayurveda |
| Address |
Room No 114, panchkarma department, national institute of ayurveda, jorawar singh gate, jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
7976818419 |
| Fax |
|
| Email |
Kabhi9615@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof. Dr. Gopesh mangal |
| Designation |
Professor & hod pg department of panchkarma |
| Affiliation |
National institute of ayurveda |
| Address |
Room No 114, panchkarma department, national institute of ayurveda, jorawar singh gate, jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
8619849011 |
| Fax |
|
| Email |
Gopesh.pk@nia.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Gopesh mangal |
| Designation |
Professor hod pg department of panchkarma |
| Affiliation |
National institute of ayurveda |
| Address |
Rroom No 114, panchkarma department, national institute of ayurveda, jorawar singh gate, jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
8619849011 |
| Fax |
|
| Email |
Gopesh.pk@nia.edu.in |
|
|
Source of Monetary or Material Support
|
| National institute of ayurveda, jaipur, Rajasthan, 302002, India |
|
|
Primary Sponsor
|
| Name |
National institute of ayurveda |
| Address |
Madhav vilas palace,jorawar singh gate, amber road,jaipur, rajasthan india 302002. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Abhishek Ranjan Jha |
National Institute Of Ayurveda |
Room 111, Panchkarma Department, Jorawar Singh Gate, Amer Road,Jaipur 302002 Jaipur RAJASTHAN |
7976818419
kabhi9615@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee of national institute of ayurveda jaipur |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amritprasha ghrita , Reference: BHAISAJYA RATNAVALI 74 285 296,, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: - | | 2 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: CHARAK SIDHI 9 TRIMARMIYA ADHYAY 53 57,, Procedure details: 20 ML TAIL ADMINISTRATION BY INFANT TUBE/ RUBBER CATHER/ FOLEYS CATHATER THROUGH SYRINGE )) (1) Medicine Name: VIDANGAADYA TAIL , Reference: CHARAK SIDHI 4 SNEHVYAPAD SIDHI 18 22, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 15 Days | | 3 | Intervention Arm | Procedure | - | svedanam, सà¥à¤µà¥‡à¤¦à¤¨à¤®à¥ | (Procedure Reference: CHARAK SUTRA 14 SVEDANIYA ADHYAYA, Procedure details: STHANIK MRIDU SVEDANA ON UPASTHA ( PENIS SHAFT REGION) WITH PREMAHMIHIR TAIL ) (1) Medicine Name: PREMAHA MIHIR TAILA, Reference: BHAISAJYA RATNAVALI 37 221 229, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1 Age : 18 to 60 years
2 Gender : Male
3 Patients presenting with Samanya Lakshana of
Klaibya (Erectile Dysfunction)
4 Unable to consummate 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 Spinal cord injury.
2 Major organic or psychosomatic disorder.
3 Poorly controlled Diabetes mellitus, Severe
Systemic diseases, Uncontrolled hypertension.
4 ED due to surgery of colon, prostate, bladder
or rectum.
5 Carcinoma of penis.
6 Hypospadias.
7 Phimosis.
8 Patients with possible effects of any
medication.
9 Patients with Venereal disease, HIV.
10 Congenital chordee
11 Congenital defect of genital organ |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in score of Patient Questionnaire from
International Index of Erectile Function (IIEF)
2.Clinical Interpretation of Mlanashishnata-
a. No erection at all
b. Erection but not sustained
c. Sustained erection
d. Erection but not enough for penetration
e. Erection enough for penetration Successful
intercourse |
at baseline, after 2 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome of the study will be
assessed by changes of DSM V criteria score. |
after 4 weeks of complete treatment |
|
|
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)
|
30/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="29" |
|
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
|
INTRODUCTIONInability to obtain or maintain an adequate erection for satisfying sexual activity is known as erectile dysfunction (ED). The achievement of a proper erection with enough stiffness for penetrative intercourse is the most crucial of the many phases off sexual response ;failure and unhappiness result from the absence of this phase. In classical ayurvedic texts, this condition is carefully described as Klaibya. Importantly, ED has a significant negative impact on a man’s quality of life, including loss of self-esteem, avoidance of intimacy, anxiety and depression, which in turn exacerbate sexual dysfunction. This also impacts the relationship between sexual partners, including negatively affecting sexual desire and satisfaction of partners. Furthermore, ED is considered an independent risk factor for the development of metabolic syndrome, cardiovascular disease and type 2 diabetes mellitus, sharing common underlying mediators, and therefore ED is considered an increased mortality risk. Its incidence increases drastically from about 6% in the age group 20-29 years, to 50-70% in the age group 40-79 years Its incidence has been projected to increase significantly to over 320 million by the year 2025. India has been dubbed as the impotence capital of the world due to the high incidence of the life style diseases and probably the largest population of males in the world. It has been selected for the present study to find out a better cure for a happy and healthy sexual life. After considering these facts present work is formulated to assess the efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir Taila Upasth Basti followed by Amritprash Ghrita in the management of Klaibya w.s.r. erectile dysfunction. RESEARCH QUESTION Is there any efficacy of Vidangaadya tail Uttar basti and Pramahamihir tail Upasth basti followed by Amritprash Ghrit in the management of Klaibya with special reference to erectile dysfunction? HYPOTHESIS Ho There is no efficacy of Vidangaadya Tail Uttar Basti and Pramahamihir Tail Upasth Basti followed by Amritprasha Ghrit in the management of Klaibya with special reference to erectile dysfunction. HA There is effect of Vidangaadya Tail Uttar Basti and Pramahamihir Tail Upasth Basti followed by Amritprasha Ghrit in the management of Klaibya with special reference to erectile dysfunction. AIM OF THE STUDY To evaluate the efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir tail Upasth Basti in the followed by Amritprash Ghrit in management of Klaibya with special reference to erectile dysfunction. OBJECTIVE OF THE STUDY To evaluate the clinical efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir Tail Upasth Basti in Klaibya with special reference to erectile dysfunction. |