| CTRI Number |
CTRI/2024/09/073818 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TREATMENT FOR MALE INFERTILITY |
|
Scientific Title of Study
|
AN OPEN LABELLED RCT STUDY TO ASSESS THE COMBINED EFFECT OF VIRECHANA UTTARABASTI SARIVACHATUSHKA RASAYANA WITH AMRITA PRASHA GHRITA ANUPANA OVER ONLY KUSTA KOKILAKSHADI RASAYANA WITH AMRITA PRASHA GHRITA ANUPANA IN KSHEENA SHUKRA(OLIGOASTHENOZOOSPERMIA) |
| 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 KEDARNATH J |
| Designation |
DEPT OF PG STUDIES IN KAYACHIKISTA |
| Affiliation |
TARANATH GOVT AYURVEDIC MEDICAL CILLEGE AND HOSPITAL.BALLARI |
| Address |
TARANATH GOVERNMENT AYURVEDIC MEDICAL COLLEGE AND HOSPITALRAJKUMAR ROAD BALLARI
Hospital building kayachikista OPD Room number 1
Bellary
KARNATAKA
583101
India |
| Phone |
7090185846 |
| Fax |
260273 |
| Email |
kedarnathj2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MADHAVA DIGGAVI |
| Designation |
BAMS MD |
| Affiliation |
TARANATH GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL.BALLARI |
| Address |
TARANATH GOVERNMENT AYURVEDIC MEDICAL COLLEGE AND HOSPITALRAJKUMAR ROAD BALLARI
Bellary
KARNATAKA
583101
India |
| Phone |
9844094290 |
| Fax |
260273 |
| Email |
drmvdbly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MADHAVA DIGGAVI |
| Designation |
BAMS MD |
| Affiliation |
TARANATH GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL.BALLARI |
| Address |
TARANATH GOVERNMENT AYURVEDIC MEDICAL COLLEGE AND HOSPITALRAJKUMAR ROAD BALLARI.HOSPITAL BUILDING KAYACHIKISTA OPD ROOM NUMBER 01.
Bellary
KARNATAKA
583101
India |
| Phone |
9844094290 |
| Fax |
260273 |
| Email |
drmvdbly@gmail.com |
|
|
Source of Monetary or Material Support
|
| PHARMACY SECTION OF TARANATH GOVERNMENT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL.BALLARI 583101.KARNATAKA INDIA |
|
|
Primary Sponsor
|
| Name |
DR KEDARNATH J |
| Address |
TARANATH GOVERNMENT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL. RAJKUMAR ROAD BALLARI 583101 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR KEDARNATH J |
TARANATH GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL. BALLARI. HOSPITAL BUILDING KAYACHIKISTA OPD ROOM NUMBER 01 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KEDARANTH J |
TARANATH GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL . |
TARANATH GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
,Hospital building Kayachikista OPD Room Number 1 Ballari 583101
Bellary
KARNATAKA |
7090185846
260273
kedaranthj2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE OF TARANATH GOVT AYURVEDIC MEDICAL COLLEGE . BALLARI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: CHARAKA SIDDISTANA, Procedure details: VIRECHANA,NIRUHABASTI AS A POORVA KARMA FOR UTTARA BASTI WITH AMRITAPRASHA GRITHA 40 ML ON 14TH,18TH AND 22ND DAY AFTERNOON ON THE DAY OF ADDMINISTRATION OF ARDAMATRIKA NIRUHA BASTI)
(1) Medicine Name: AMRUTAPRASHANA GRITHA, Reference: CHARAKA CHIKITSA - 11, Route: Urethral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Duration: 48 Days(2) Medicine Name: SARIVA CHATUSKA, Reference: BHAVAPRAKASHA NIGANTU, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Duration: 25 Days | | 2 | Intervention Arm | Procedure | - | KOSTHASHODHANA | (Procedure Reference: CHARAKA SIDDISTHANA, Procedure details: KOSTHASHODHANA WILL BE GIVEN WITH PAYASAERANDATAILA 50ML ON EMPTY STOMACH )
(1) Medicine Name: KUSHTAKOKILAKSHADI RASAYANA , Reference: BHAVAPRAKASHA NIGHANTU, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Duration: 39 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
DIAGNOISED CASE OF OLIGOASTHENOZOOSPERMIA.
SPERM COUNT LESS THAN 15 MILLION/ML
MOTILITY LESS THAN 40%
SUBJECTS WHO WILL SIGN FOR INFORMED CONSENT
SUBJECTS FIT FOR VIRECHANA,NIRUHA BASTI , UTTARABASTI |
|
| ExclusionCriteria |
| Details |
SUBJECTS WITH AZOOSPERMIA
SUBJECTS WITH CONGENITAL DISSORDERSRELEATED TO REPRODUCTIVE SYSTEM LIKE BILATERAL ABSENCE OF VASDEFERENCE,CRYPTORCHIDISL,MARFANS SYNDROM,KLINEFELTER SYNDROME |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN THE SPERM COUNT |
48 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN THE OBJECTIVE CRITERIA |
48 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/09/2024 |
| 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="0"
Months="0"
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
|
Oligoasthenozoospermia refers to semen with low concentration of sperm less than 15 million per ml and reduced sperm motility less than 40%(RLP+SLP). It is ksheena shukra which is one of the astavidha shukra dusti , dominant with vatapitta vitiation.Ksheena shukra is characterised by qualitative and quantitative reduction of shukra dhatu. treatment modalities like virechana, niruha, anuvasana and uttara basti are indicated in ksheena shukra. 45% of infertile men were found to be affected by oligozoospermia. 100% immotile spermatozoa in the ejaculate, is reported at a frequency of 1 in 5000men With a research question whether virechana, uttarbasti followed by sariva chatushka rasayana with amrita prasha ghrita as anupana is effective in one arm or whether alone shamana with kusta kokilakshadi rasayana with amritaprasha ghrita in other arm will improve the CASA based semen parameters or not |