| CTRI Number |
CTRI/2024/10/075285 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Treatment in Patients of Erectile dysfunction |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF PRATHAMA BALADI YAPANA BASTI, MADHUTAILIKA BASTI, DWIPANCHAMOOLADI BASTI WITH ANALOGOUS SHAMANA IN THE MANAGEMENT OF KLAIBYA VIS-A-VIS 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 Mahadev Sogi |
| Designation |
Assistant professor |
| Affiliation |
AYURVEDA MAHAVIDYALAYA HUBLI |
| Address |
Shri C B Guttal ayurveda medical college, Kayachikitsa Department
Room no 10
Dharwad
KARNATAKA
580001
India |
| Phone |
8277245218 |
| Fax |
|
| Email |
sogimahadev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashant A S |
| Designation |
Professor and HOD |
| Affiliation |
ayurveda mahavidyalaya, huballi |
| Address |
Ayurveda Mahavidyalaya College
Hubli, Kayachikitsa Department,Room no 6
Dharwad
KARNATAKA
570002
India |
| Phone |
9448114773 |
| Fax |
|
| Email |
Drprashanthas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr santosh N Belavadi |
| Designation |
professor and HOD |
| Affiliation |
professor and HOD |
| Address |
DGM AYURVEDA MEDICAL COLLEGE ,GADAG.
Kayachikitsa Department Room no1
Gadag
KARNATAKA
582103
India |
| Phone |
9886916367 |
| Fax |
|
| Email |
hardikasnb@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYURVEDA MAHAVIDYALAYA HUBli
karnataka,india,570002 |
|
|
Primary Sponsor
|
| Name |
Dr Mahadev Sogi |
| Address |
Ayurveda Mahavidyalaya Hubli,570002.
India
|
| Type of Sponsor |
Other [self] |
|
|
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 Prashant A S |
AYURVEDA MAHVIDYALAYA HUBLI,KARNATAKA-570002 |
KAYACHIKITSA DEPARTMENT
ROOM NO - 6
Dharwad
KARNATAKA |
9448114773
drprashanthas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical comitee |
Approved |
|
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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: ashwganda taila, Reference: classical, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Procedure | - | anuvAsana-bastiH, अनà¥à¤µà¤¾à¤¸à¤¨-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: classical, Procedure details: Anuvasana Basti with Sukumara taila in Madhyama matra. Dwipanchamooladi Niruha Basti in Madhyama Matra (kala basti schedule)))
| | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vrushya gutika, Reference: classical, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: haritakyadi choorna, Reference: charaka smhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Subjects age group of 21 years to 50 years.
2. Subjects with classical symptoms of Klaibya like Linga Shaithilya, Mlana Shishnata, Mogha Sankalpa Cheshta, Dhvajanucchraya, Surata ashaktata.
3. Subjects fit for Basti treatment protocol.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with Congenital disorder of Gonads.
2. Subjects with other Systemic disease and Severe Metabolic issues. Evidence of STD, Carcinoma, AIDS, TB, other disease like Phimosis, venereal diseases, Communicable herpes, Ulceration, Hydrocele, Spinal cord lesions and surgeries.
3. Subjects who are not fit for scheduled Basti protocol.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of functional improvement
after intervention |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of effect of different intervention. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 4 |
|
Date of First Enrollment (India)
|
27/10/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
•1. Litrature of ayurveda emphasises treatment
modality
for klaibya are Basti chikitsa, vajeekarana chikitsa with vrishya yoga
and rasayana chikitasa were clasicaaly followed.11
2. •In Ayurveda before administration of any
medicine especially Rasayana and Vajeekarana the Ama Pachana and Koshtashodhana plays
a key role in enhancing the absorption of medicine
hence Haritakyadi choorna (yoga) is administered
before Basti intervention.19
3. •Basti karma has been principal
intervention in Ayurveda. Though it has been indicated for almost all the
diseases, the prime importance of Basti karma has been specified
in the management of Klaibya. Basti is indicated for providing
rejuvenation, happiness, increasing the duration of life, strength, improving
memory, voice, digestive power and complexion. It removes noxious matters from
the tissues, pacifies the Dosha and rectifies the process of
excretion. Consequently it affords stability and thus indirectly strengthens
the reproductive capacity in subjects.12
4. Therefore this study is undertaken to
evaluate the efficacy
of Prathama Baladi Yapana Basti, 20Madhutailika
Basti,21 Dwipanchamooladi Basti 22 with analogous Shamana in
the management of Klaibya VIS-À-VIS Erectile Dysfunction.
|