| CTRI Number |
CTRI/2022/11/047297 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
14/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Clinical evaluation of siddha medicine Muppirandai chooranam for heavy menstrual bleeding. |
|
Scientific Title of Study
|
Phase II non randomized open clinical evaluation of siddha medicine Muppirandai chooranam for pitha perumbadu (Menorrhagia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R SHANTHINI |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College |
| Address |
POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI 106
Chennai
TAMIL NADU
600106
India |
| Phone |
7299320319 |
| Fax |
|
| Email |
shanthinishrinky@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANBU N |
| Designation |
HOD and Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R SHANTHINI |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College |
| Address |
POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI 106
Chennai
TAMIL NADU
600106
India |
| Phone |
7299320319 |
| Fax |
|
| Email |
shanthinishrinky@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI 106 |
|
|
Primary Sponsor
|
| Name |
Dr R SHANTHINI |
| Address |
POST GRADUATE DEPARTMENT OF PG POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI 106 |
| Type of Sponsor |
Other [Government Siddha 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 R Shanthini |
Arignar anna govt hospital of indian medicine and homeopathy attached with GSMC |
OP no S1 PG Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai 106
Chennai
TAMIL NADU |
7299320319
shanthinishrinky@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MUPPIRANDAI CHOORANAM |
This Siddha herbal drug will be given as 1 gram, BD dose with honey, for 3 consecutive cycles for the management of Menorrhagia |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Excessive menstruation (Bleeding - one or more pads or tampons every 2 hours) Prolonged menstruation (Bleeding - lasts longer than eight days)Puberty menstruation Premenopausal menorrhagia Menorrhagia in PCOD Hb level above 8gms |
|
| ExclusionCriteria |
| Details |
Fibroid polyp Bleeding disorders
Hypothyroidism Abortion and pregnancy Ovarian feminizing tumour Adenomyosis Chocolate cyst Uterine fibroids Endometrial cancer Uterine sarcomas |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced amount of Menstrual blood flow is assessed by number of sanitary pads used before and after treatment by the chart PICTORIAL BLOOD ASSESSMENT CHARTS (PBAC) |
The outcome will be assessed by reduction in the clinical symptoms for 3 consecutive cycles. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hb will be monitored |
Improvement of Hb will be monitored in the fourth consecutive cycle. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/11/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
HMB or menorrhagia is the most common complaint among AUB. It is generally caused by conditions affecting the uterus or its vascularity, rather than disturbances in Hypothalamic - Pituitary - Ovarian (H-P-O) axis. Symptoms of HMB may include, bleeding through one or more pads or tampons every one or two hours, passing blood clots larger than the size of quarters, bleeding that often lasts longer than eight days, Inability to perform regular daily activities because of the bleeding. Menorrhagia affects up to 30% of women in their reproductive period. Over 5% of women ages between 30-49 years consult gynaecologist each year with this complaint. Thus, in Siddha system of Medicine, there are unique combination of medicines, which have solution to the present scenario of excessive or prolonged menstrual bleeding. One such combination is MUPPIRANDAI CHOORANAM which will be cost effective and reliable. The aim of the study is the management of PITHA PERUMBADU (MENORRHAGIA) with siddha medicine MUPPIRANDAI CHOORANAM and the objective is to determine the therapeutic efficacy and safety profile of the siddha medicine MUPPIRANDAI CHOORANAM in the management of PITHA PERUMBADU (MENORRHAGIA). As the literary evidences support the usage of medicine, in the disease, hypothesis is created such a way that the efficacy of MUPPIRANDAI CHOORANAM will be a better solution for PITHA PERUMBADU (MENORRHAGIA). |