| CTRI Number |
CTRI/2014/06/004646 [Registered on: 02/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
03/06/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on Aanmai kuraivu [Male Infertility]with trial drug Nerunjil vithai chooranam. |
|
Scientific Title of Study
|
An open pilot clinical study on Aan maladu [Male Infertility]with the evaluation of trial drug Nerunjil vithai chooranam. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T NATARAJAN |
| Designation |
P.G SCHOLAR |
| Affiliation |
Government siddha medical college |
| Address |
Department of Pothu maruthuvam,Government siddha medical college,Arumbakkam,Chennai 106.
Department of Pothu maruthuvam,Government siddha medical college, Arumbakkam Chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
8939277097 |
| Fax |
|
| Email |
drnataraj88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF Dr P PARTHIBAN |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Government siddha medical college |
| Address |
Department of Pothu maruthuvam,Government siddha medical college,Arumbakkam, Chennai 106
Department of pothu maruthuvam,Government siddha medical college, Arumbakkam,Chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
9444284684 |
| Fax |
|
| Email |
parniru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K KANAKAVALLI |
| Designation |
LECTURER |
| Affiliation |
Government siddha medical college |
| Address |
Department of pothu maruthuvam,Government siddha medical college,Arumbakkam,Chennai 106.
Department of pothu maruthuvam,Government siddha medical college,Arumbakkam,Chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
9444122865 |
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college
|
|
Primary Sponsor
Modification(s)
|
| Name |
NIL |
| Address |
Department of pothu maruthuvam,
Government siddha medical college, Arumbakkam,Chennai 106 |
| Type of Sponsor |
Other [NIL] |
|
|
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 T NATARAJAN |
Arignar Anna Govt.Siddha Hospital |
Arignar Anna Govt.Siddha Hospital,Dept Of Pothu Maruthuvam,Room No 4c,Arumbakkam.
Chennai
TAMIL NADU |
8939277097
drnataraj88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
MALES WITH INFERTILITY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nerunjil vithai chooranam |
2gm twice a day with milk by oral route for 48 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Oligospermia,
Oligoasthenospermia,
Willing to give semen for investigation. |
|
| ExclusionCriteria |
| Details |
Diabetes mellitus ,
Hypertension,
Cardiac diseases,
Hydrocele,
Azoospermia,
Vericocele. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Semen Analysis is done before and after treatment. |
After 48 days of treatment semen analysis is repeated. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LFT and RFT is measured before and after treatment. |
After 48 days of treatment saftey parameters are repeated. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/05/2013 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Nerunjil vithai chooranam is a polyherbal formulation, main ingredients are asparagus resemosus,mucuna pruriens,tribulus terrestris. In literature all ingredients of NVC have aphrodisiac action. NVC is a safest and most effective for male infertility. 20 patients included in the trial and trial drug is given and monitered. |