| CTRI Number |
CTRI/2015/08/006102 [Registered on: 18/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
14/08/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL STUDY ON DIAGNOSTIC METHODOLOGY SYMPTOMATOLOGY AND LINE OF TREATMENT FOR THE DISEASES OF WOMEN DURING REPRODUCTIVE PERIOD |
|
Scientific Title of Study
|
A CLINICAL STUDY ON DIAGNOSTIC METHODOLOGY SYMPTOMATOLOGY AND LINE OF TREATMENT OF PRE MENSTRUAL SYNDROME |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PUNITHA PRIYATHARSINI T |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894169202 |
| Fax |
|
| Email |
lingapass15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J Christian |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
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 G J Christian |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Tamilnadu |
| 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 T Punitha Priyatharsini |
NATIONAL INSTITUTE OF SIDDHA |
OP NO 5
Department of noinaadal
National Institute of Siddha
Tambaram Sanatorium
Chennai 47
Kancheepuram
TAMIL NADU |
9894169202
lingapass15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS WITH JOINTPAIN HEADACHE DEPRESSION WEIGHT LOSSS EXCESSIVE THIRST VOMITTING, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
PATIENTS WITH JOINTPAIN HEADACHE CONFUSION DEPRESSION WEIGHT LOSS |
|
| ExclusionCriteria |
| Details |
VULNERABLE GROUP ANY MAJOR AND SYSTEMIC ILLNESS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO RULE OUT THE DIAGNOSTIC METHODOLOGY AND SYMPTOMATOLOGY OF SURONITHA PITHAM |
ONE MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ANALYSE THE SYMPTOMS AND METHODOLOGY OF SURONITHA PITHAM |
ONE MONTH |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/08/2015 |
| 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) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Premenstrual syndrome (PMS) refers to a varied collection of physical and emotional symptoms during part of a woman’s menstrual cycle. While most women of child-bearing age report having experienced physical symptoms related to normal ovulatory function.PMS can be control or prevented by the maintaining healthy lifestyle, practicing yoga in daily life, and by increasing physical activity. Symptoms of PMS is a inevitable part of women’s life. So every women want to get awareness about PMS and its treatment in Siddha system of medicine.So the investigator wants to analyse the diagnostic methodology for PMS in siddha system of medicne. |