| CTRI Number |
CTRI/2018/02/011798 [Registered on: 09/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on menorrhagia |
|
Scientific Title of Study
|
Clinical evaluation of Odhiyampattai kudineer a siddha drug for Vali Perumpadu -as a Pilot study |
| Trial Acronym |
Vali perumpadu. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PAlarmelmangai |
| Designation |
pg scholar |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha
Department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
National institute of siddha
Department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9677146683 |
| Fax |
|
| Email |
eq.alarmelmangai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMAmalahazel |
| Designation |
Lecturer |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha
Department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
National institute of siddha
Department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9940429202 |
| Fax |
|
| Email |
dramalaaruldhas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMAmalahazel |
| Designation |
Lecturer |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha
Department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
National institute of siddha
Department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9940429202 |
| Fax |
|
| Email |
dramalaaruldhas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha AyoYhidass hospital tambaram sanatorium |
| 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 |
| PAlarmelmangai |
National Institute of siddha |
National Institute of siddha
Tambaram sanatorium
Chennai 600047
Chennai
TAMIL NADU |
9677146683
eq.alarmelmangai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
excessive or prolonged menstrual bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
odhiyampattai kudineer |
oral administration 50 ml b.d. for 7 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age: 16-40 years
Patient having the symptoms of increased reddish black menstrual bleeding.
Blood clots seen in the menstrual bleeding
Patient willing to undergo routine blood investigation.
Patient willing to participate in trial and signing in consentform.
Patient willing to undergo Usg_pelvis( to rule out any pelvic pathology etc)
|
|
| ExclusionCriteria |
| Details |
1.Fibroid uterus
2.Endometriosis
3.Adenomyosis
4.Uterine cancer
5.Endometritis
6.Cardiac disease
Renal disease
Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The reduction of menstrual bleeding with Pbac score. |
after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of the drug,in regulating the menstrual flow in the future period,adverse effect of the drug if any |
after 30 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
24/07/2016 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
After completion of the trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an Open clinical trial, to evaluate the therapeutic efficacy of ODHIYAMPATAI KUDINEER (internal medicine) from the siddha texts gunapadam mooligai vaguppu. The ingridients are odhiyampattai coarse powder decoction of 50 ml orally b.i.d. The treatment will be given for 7 days. The Laboratory investigations and Clinical assessments will be recorded periodically before and after treatment period. All the trial related data will be recordered in Case Report Form (CRF) for each patient separately. At the end of trial all the data will be analysed statistically and the research reports will be Published |