| CTRI Number |
CTRI/2023/10/058832 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
20/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on low sperm count by giving Kalnar Parpam Tablet |
|
Scientific Title of Study
|
TO DETERMINE THE EFFECTIVENESS OF KALNAR PARPAM IN THE MANAGEMENT OF VINDHU NATTAM (OLIGOSPERMIA) AMONG OUTPATIENTS ATTENDING AYOTHIDOSS PANDITHAR HOSPITAL, NATIONAL INSTITUTE OF SIDDHA – A PILOT STUDY |
| 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 S LALITHAKUMARI |
| Designation |
Medical Officer |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9994533518 |
| Fax |
|
| Email |
dhanabalan1972@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr GJ CHRISTIAN MDSiddha PhD |
| Designation |
Hospital Superindantent (i/c), Professor and Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S LALITHAKUMARI |
| Designation |
Medical Officer |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9994533518 |
| Fax |
|
| Email |
dhanabalan1972@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
Dr S Lalithakumari |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai 600047 |
| 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 S LALITHAKUMARI |
AYOTHIDOSS PANDITHAR HOSPITAL, NATIONAL INSTITUTE OF SIDDHA |
Department of Sool Mahalir Maruthuvam, Room No. 17, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU |
9994533518
dhanabalan1972@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N461||Oligospermia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Kalnar Parpam Tablet |
2 Tablets twice a day with Ghee or Butter for 90 days |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1. Patient having abnormalities of Semen parameters Oligozoospermia (Sperm count < 15 million/ml).
2. Poor motility, poor quantity and quality of seminal fluid
3. Willing to sign the consent form for enrollment in the study. |
|
| ExclusionCriteria |
| Details |
1. Azoospermia
2. K/C/O testicular varicocele and hydrocele
3. K/C/O Filiariasis
4. History of Undescended testis
5. Genetic issues
6. Patients having chronic illness or tumors
• Any anatomical defects
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in semen parameters such as sperm count, volume, viscosity both in quality and quantity, morphology will be assessed by semen analysis |
90 days |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
25/10/2023 |
| 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 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
|
This is a Single arm Phras-1 Experimental study to determine the effectiveness of Kalnar Parpam in the management of Vindhu Nattam (Oligospermia) among outpatients attending ayothidoss pandithar hospital, national institute of siddha in 10 Male Patients. The study will be conducted among the adult patients with oligozoospermia having sperm count below 15 million / ml, poor motility, Poor quantity and quality of seminal fluid who approaches to Ayothidoss Pandithar hospital, NIS, Chennai. Trial participants will be included based on Inclusion and Exclusion criteria. After enrolment trial drug Kalnar Parpam tablet will be given as 2 tablets twice a day with ghee or butter for 90 continues days. Outcome of the trial will be assessed through improvement in semen parameters such as sperm count, volume, viscosity both in quality and quantity will be assessed by semen analysis. |