| CTRI Number |
CTRI/2024/05/067959 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to determine the yakkai ilakkanam in abnormal uterine bleeding patients attending OPD National Institute of Siddha |
|
Scientific Title of Study
|
An observational study to determine the possible association between specific yakkai ilakkanam (Siddha somatotype) in patients with Abnormal uterine bleeding Perumbadu |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KOUSALYA S |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 20/21 Department of Noi Naadal,Ayothidoss Pandithar Hospital,Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
9962005139 |
| Fax |
|
| Email |
skousalya254@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Srinivasan |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 20/21 Department of Noi Naadal,Ayothidoss Pandithar Hospital,Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
9965962592 |
| Fax |
|
| Email |
seenunis47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Srinivasan |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 20/21 Department of Noi Naadal,Ayothidoss Pandithar Hospital,Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
9965962592 |
| Fax |
|
| Email |
seenunis47@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 20/21, Department of Noi Naadal,Ayothidoss Pandithar HospitalNational Institute of Siddha, Tambaram Sanatorium, Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 S Kousalya |
Ayothidoss Pandithar Hospital |
Room no 20/21, Department of Noi Naadal,National Institute of Siddha, Tambaram Sanatorium, Chennai 600047
Chennai
TAMIL NADU |
9962005139
skousalya254@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N926||Irregular menstruation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Subject is assessed with PBAC for abnormal uterine bleeding with the following conditions- Fibroid uterus, Adenomyosis, Pelvic endometriosis, Dysfunctional uterine bleeding, Chronic tubo ovarian mass, Endocrinal - hypothyroid and hyperthyroid, Hematological cause and are included in the study |
|
| ExclusionCriteria |
| Details |
Patient not willing to sign the consent form
Patients with any serious system illness
Metrorrhagia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The possible association of Dhegi characterization in Perumbadu patients will be obtained. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Naadi in the subjects of the study will be documented.
The affected humors in the subjects will be evaluated through the panchapatchi calculation.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
27/05/2024 |
| 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="2"
Months="0"
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
|
PRIMARY OBJECTIVE:· To determine the possible association of specific disease uterine bleeding (Perumbadu) on the basis of Dhegi characterisation.
SECONDARY OBEJECTIVE: To study the relationship of panchapatchi calculation with perumbadu in the subjects included in the research. To document the specific siddha diagnostic methodology naadi in the subjects. Study type: An Observational study, Study design:Cross sectional study- Case control study
INCLUSION CRITERIA :Age :18-55 years. Subject is assessed with PBAC for abnormal uterine bleeding with the following conditions- Fibroid uterus, Adenomyosis, Pelvic endometriosis, Dysfunctional uterine bleeding, Chronic tubo ovarian mass, Endocrinal - hypothyroid and hyperthyroid, Hematological cause and other causes and are included in the study. EXCLUSION CRITERIA ·Patient not willing to sign the consent form · Patients with any serious system illness ·Metrorrhagia PRIMARY OUTCOME: · The possible association of Dhegi characterization in Perumbadu patients will be obtained. SECONDARY OUTCOME · The Naadi in the subjects of the study will be documented. · The affected humors in the subjects will be evaluated through the panchapatchi calculation
RESULTS AND DISCUSSION: The results will be statistically analysed and reported.
KEY WORDS: Dhegi, Yakkai ilakkanam, Siddha, Perumbadu, Abnormal uterine bleeding.
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