| CTRI Number |
CTRI/2023/02/049786 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
15/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical assessment of Navauppu Mezhugu for Painful menstruation. |
|
Scientific Title of Study
|
A Study on effectiveness of Nava Uppu Mezhugu for Aga Soothaga Vali (Primary Dysmenorrhoea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megganah |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
TamilNadu
India
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
TamilNadu
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
6381372797 |
| Fax |
|
| Email |
drmegumd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Vennila |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
TamilNadu
India
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
TamilNadu
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9789093986 |
| Fax |
|
| Email |
gvennils@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megganah |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
TamilNadu
India
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
TamilNadu
India
TAMIL NADU
600047
India |
| Phone |
6381372797 |
| Fax |
|
| Email |
drmegumd@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium
Chennai-47
TamilNadu
India |
|
|
Primary Sponsor
|
| Name |
Dr Megganah |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
TamilNadu
India |
| 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 Megganah S S |
NATIONAL INSTITUTE OF SIDDHA |
OP NO 17, Department of Kuzhanthai Maruthuvam(Sool Magalir)
National institute of Siddha,
Tambaram sanatorium,
Chennai _47.
Kancheepuram
TAMIL NADU |
6381372797
drmegumd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N946||Dysmenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NAVA UPPU MEZHUGU(INTERNAL) |
Dosage: 35-40 mg (Only in the morning)
Adjuvant: Palm jaggery
Duration :3 days of menstruation for 3 consecutive months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Women in the age group between 11 to 25 years
Onset of pain within 6-12 hours after the onset of menses
Nulliparous women
Cramping or pain in the lower abdomen
Pelvic pain
Low back pain
Pain spreading down the legs.
Patient willing to sign the informed consent. |
|
| ExclusionCriteria |
| Details |
Presence of any pelvic pathology such as chronic pelvic infection, pelvic
endometriosis, adenomyosis, uterine fibroid and endometrial polyp
Presence of any associated severe systemic illness
Uterine or cervical polyp |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significance reduction in clinical symptom assessed by using WaLIDD score. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
17/02/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION:Gynaecology
is the medical practice which deals with the female reproductive system.
Dysmenorrhoea is a frequent and misdiagnosed symptom affecting the quality of
life in women. Every woman experiences at least a minimum level of
pain during menstruation in their life time. But Dysmenorrhoea is defined as
the severe and frequent menstrual cramps and pain during the menstrual period.
Dysmenorrhoea is the painful periods that affects 16% to 91% of woman which
makes embarrassing to get into social gathering & even engage in personal
life. It is classified as primary and secondary dysmenorrhoea.The primary
dysmenorrhoea is one where there is no identifiable pelvic pathology. Increased
prostaglandin secretion intensifies uterine contractions, causing symptoms like
Cramping in the lower abdomen, Pain in the lower abdomen, Low back pain, Pain
radiating down the legs, Nausea, Vomiting, Diarrhoea and Fatigue. Due to this
there is a need to study about the effectiveness of Nava Uppu Mezhugu, which is
indicated for the management of Primary dysmenorrhoea. This study is to assess
the improvement in clinical symptoms of Primary dysmenorrhoea using WaLIDD
score, before and after treatment after the intake of trial medicine, Nava Uppu
Mezhugu. MATERIALS AND METHODS: An open clinical trial will be conducted
in OPD of Ayothidoss Pandithar Hospital, National Institue of Siddha, Tambaram
Sanatorium, Chennai. A total of 10 diagnosed patients of Aga Soothaga
Vali (Primary Dysmenorrhoea) within the age limit of 18 to 25 years who are
willing to participate in the study by signing the consent form will be
enrolled based on the inclusion and exclusion criteria. The trial drug Nava
Uppu Mezhugu will be given to the patients in 3 days of menstruation for 3
consecutive months. RESULTS AND DISCUSSION: The effectiveness of the
trial drug is measured by significance reduction in clinical symptom assessed
by using WaLIDD score and the discussion will be done according to the results.KEY
WORDS: Primary Dysmenorrhoea, Misdiagnosed symptom, Increased
prostaglandin, WaLIDD score
|