| CTRI Number |
CTRI/2017/05/008615 [Registered on: 22/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to study the effect of the Drug Naaval nei in patients with high bleeding during menstruation |
|
Scientific Title of Study
|
A clinical study on Pitha Perumbadu (Menorrhagia) with the evaluation of Siddha drug Naaval nei. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Jayapriya |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College |
| Address |
Govt Siddha Medical College
6, Anna arch Road NSK Nagar
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9894529964 |
| Fax |
|
| Email |
jpsubi2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Anbu |
| Designation |
Head Of The Department |
| Affiliation |
Govt Siddha Medical College |
| Address |
Govt Siddha Medical College
6, Anna arch Road NSK Nagar
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Jayapriya |
| Designation |
Pg Scholar |
| Affiliation |
Govt Siddha Medical College |
| Address |
Govt Siddha Medical College
6, Anna arch Road NSK Nagar
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9894529964 |
| Fax |
|
| Email |
jpsubi2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Siddha Medical College, Arumbakkam, Chennai-106 |
|
|
Primary Sponsor
|
| Name |
Govt Siddha Medical College |
| Address |
6
Anna arch Road
NSK Nagar
Arumbakkam
Chennai 106 |
| Type of Sponsor |
Government medical college |
|
|
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 Jayapriya |
Arignar Anna Government Hospital of Indian Medicine |
Room no 2
Siddha division
General medicne department
Arignar Anna Government Hospital of
Indian Medicine and
Homeopathy
Anna arch road
NSK Nagar
Arumbakkam
Chennai
TAMIL NADU |
9894529964
jpsubi2009@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 |
Pitha Perumbadu (Menorrhagia), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Naaval Nei |
5 ml of Naaval nei is administered thrice a day for 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients with the following signs and symptoms
Excessive menstruation
Prolonged menstruation
Presence of Blodd clots in menstrual bleeding
Lower abdominal pain
Low back ache
Triedness during menstruation
Giddiness during menstruation
Head ache durring menstruation
USG report with Fibroid uterus or PCOD or Ovarian cyst
|
|
| ExclusionCriteria |
| Details |
Pelvic pathology
Diabetes mellitus
Hypertension
Patients having IUCD
Abortion
Thrombocytopenic purpura
Coagulopathy
Severe Anemia (<6 gm)
Hypothyroidism
Vulnerable population such as HIV and TB affected individuals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome is mainly assessed by reduction in clinical symptoms and by comparing the following parameters before and after treatment.
Reduced amount of blood flow is assessed by bleeding time, clotting time And Haemoglobin |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
26/09/2016 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single arm open clinical trial to study the safety and efficacy of Siddha trial drug Naaval nei. The trial drug is given 5 ml twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Naaval nei is mentioned in aathmaratchamirtha Vaithiya Saara Sangiragam. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically. |