| CTRI Number |
CTRI/2024/02/063209 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluvate the Effectiveness of Siddha Varmam management in Thathu Nattum [Oligospermia] |
|
Scientific Title of Study
|
To Evaluvate the Effectiveness Of Siddha Varmam Points in Thathu Nattum [Oligospermia] – 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 G Thirunarayanan |
| Designation |
Medical Officer |
| Affiliation |
National Institute of Siddha |
| Address |
Room no : 20
Department of Noi Nadal,
National Institute of Siddha
(An Autonomous body under the Ministry of AYUSH)
Govt. of India.
Tambaram Sanatorium,
Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8148425747 |
| Fax |
|
| Email |
thirunarayanan.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr G J CHRISTIAN MD Siddha PhD |
| Designation |
Hospital Superindantent (i/c), Professor and Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Room no : 20
Department of Noi Nadal,
National Institute of Siddha
(An Autonomous body under the Ministry of AYUSH)
Govt. of India.
Tambaram Sanatorium,
Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Thirunarayanan |
| Designation |
Medical Officer |
| Affiliation |
National Institute of Siddha |
| Address |
Room no : 20
Department of Noi Nadal,
National Institute of Siddha
(An Autonomous body under the Ministry of AYUSH)
Govt. of India.
Tambaram Sanatorium,
Chennai.
Kancheepuram
TAMIL NADU
600 047,
India |
| Phone |
8148425747 |
| Fax |
|
| Email |
thirunarayanan.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha, Chennai - 600047 |
|
|
Primary Sponsor
|
| Name |
Dr G Thirunarayanan |
| Address |
Medical Officer,
National Institute of Siddha, 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 G Thirunarayanan |
AYOTHIDOSS PANDITHAR HOSPITAL |
Room no : 20
Department of Noi Nadal,
National Institute of Siddha
(An Autonomous body under the Ministry of AYUSH)
Govt. of India.
Tambaram Sanatorium,
Chennai – 600 047.
Kancheepuram
TAMIL NADU |
8148425747
thirunarayanan.dr@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
|
| Type |
Name |
Details |
| Intervention |
Varma Points Manipulation |
Following The Varmam points manipulations will given once in 3 days for 90 days, for 15-20 minutes.
1. Kondai Kolli Varmam is located over the bregma of the skull, Manipulated at ¼ Maathirai pressure by placing the tip of middle three finger, then press and move the finger right and left side gently for 3 times.
2. Thilartha Varmam is located over Nasion, in between frontal and nasal bone, Manipulated at ¼ Maathirai pressure by placing thumb finger , then press and rise upward gently for 3 times.
3. Poigai Varmam is Situated 2 fingers above the tragus of ear, Manipulated at ¼ Maathirai pressure by placing middle finger in the mentioned point ,then pressand rise upward for 3 times
4. Kalidai Varmam is situated at the pubic tubercule , Manipulated at ¼ Maathirai pressure by Placing thumb finger ,then press gently for 3 times.
5. Moothira Varmam is situated 4 fingers below the umbilicus, Manipulated at ¼ Maathirai pressure by placing the tip of middle finger, then press and release gently for 3 times
6. Pathaipu Varmam is situated 4 fingers below and lateral side of Moothira Varmam, Manipulated at ¼ Maathirai pressure by placing thumb finger and then press and release gently for 3 times.
7. Vithu Varmam is Situated 4 fingers below the Kalidai Varmam, Manipulated at ¼ Maathirai pressure by placing thumb finger and then press gently from medial to lateral aspect for 3 times
8. Thumbu Varmam is Situated Posterior aspect of the Scrotum Manipulated at ¼ Maathirai pressure by placing middle finger in the mentioned point ,then press and rise upward gently for 3 times.
9. Muzhangai Mel Naduku Varmam is situated 4 fingers below the Elbow (mid point of all four sides), Manipulated at ¼ Maathirai pressure by placing thumb finger and then press and release for 3 times.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Patient having abnormalities of Semen parameters Oligospermia
Poor motility, poor quantity and quality of seminal fluid
Willing to sign the consent form for enrollment in the study
|
|
| ExclusionCriteria |
| Details |
Azoospermia
K/C/O testicular varicocele and hydrocele
K/C/O Filiariasis
History of Undescended testis
Genetic issues
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 Computer Aided Semen Analysis (CASA). |
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)
|
01/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 Experimental study to determine the therapeutic effectiveness of Varmam Points based on Computer
Aided Semen Analysis (CASA) in the treatment of THAATHU NATTAM (Oligospermia) among the outpatients attending
Ayothidoss pandithar hospital, National Institute of Siddha in 10 Male Patients. The study will be conducted among adult patients with oligozoospermia having sperm count below 15 million /ml,
poor motility, Poor quantity and quality of seminal fluid who approach Ayothidoss Panditharhospital, NIS,
Chennai. Trial participants will be included based on Inclusion and Exclusion
criteria. After enrolment, Varma
Points Manipulation will be done every 3 days for 90 days. The outcome of
the trial will be assessed through improvement in semen parameters such as sperm count, volume and viscosity
both in quality and quantity, morphology will be assessed by Computer
Aided Semen Analysis (CASA). |