| CTRI Number |
CTRI/2014/01/004278 [Registered on: 03/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
02/01/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL RESEARCH OF A SIDDHA MEDICINE VEERIYA VIRUTHI CHOORANAM IN THE TREATMENT OF AAN MALADU(MALE INFERTILITY) |
|
Scientific Title of Study
|
CLINICAL STUDY ON AAN MALADU(MALE INFERTILITY)AND DRUG OF CHOICE IS VEERIYA VIRUTHI CHOORANAM. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 32111206 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V VIJAYAKUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPT. OF MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9443017837 |
| Fax |
044-22381314 |
| Email |
vasy4777@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR S MOHAN |
| Designation |
DEAN |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
drmohan139@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR H VETHA MERLIN KUMARI |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPT OF MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
044-22381314 |
| Email |
dr.vetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL |
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI |
| 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 V VIJAYAKUMAR |
AYOTHIDOSS PANDITHAR HOSPITAL |
OPD NO:1,DEPT.OF MARUTHUVAM,NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU |
9443017837
044-22381314
vasy4777@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
AAN MALADU (MALE INFERTILITY), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
VEERIYA VIRUTHI CHOORANAM |
8 gm of Veeriya viruthu chooranam will be administerd orally twice a day along with milk after food for a period of 90 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Male infertile
2. Age 21- 45 year
3. Maritial status - more than 1 year
4. Sperm count ≤ 40 million / ejaculation
5. Motility less than ≤ 50 %
6. Patient is willing to sign the informed consent stating that he will continuously stick to the treatment during 48days but can opt out of the trial of his own conscious discretion.
7. Patients who are willing to give specimen of blood , urine and semen before and after treatment.
|
|
| ExclusionCriteria |
| Details |
1. Azoospermia
2. Hydrocele
3. Diabetes mellitus
4. Hypertension
5. Endocrine disorders
6. Caridiac diseases
7. VDRL & STD
8. Inguinal Hernia
9. Renal diseases
10. Varicose veins
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is mainly assessed by increase in the sperm count and motility % |
PRE STUDY SCREENING AND AFTER TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CLINICAL ASSESSMENT |
PRE STUDY SCREENING AND AFTER TREATMENT |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2014 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single, non-randomized, open-label trial to determine the efficacy and safety of VEERIYA VIRUTHI CHOORANAM (Prepared with eleven herbal constitutents in equal proportion) in patients with Aan maladu (Male infertility).In this trial 40 male infertility patients will be recruited and the trial drug will be administered 8 gms twice a day along with milk for a period of 90 days. During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.
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