| CTRI Number |
CTRI/2019/05/019119 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
09/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial of ATTATHI CHOORANAM in the management of RAKTHA SOORAI VAAYU (POLY CYSTIC OVARIAN SYNDROME) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED, NON-RANDOMIZED, PHASE II CLINICAL TRIAL OF “ATTATHI CHOORANAM†IN THE MANAGEMENT OF “RAKTHA SOORAI VAAYU†(POLY CYSTIC OVARIAN SYNDROME) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rasenthiran Sasvatha |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Second year PG Scholar
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8883955520 |
| Fax |
|
| Email |
sasrajenthiran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MD PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD facilities and Central Library of Government Siddha Medical College and Hospital Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli |
| 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 |
| Rasenthiran Sasvatha |
Goverment Siddha Medical College and Hospital |
OP No 10
PG Department of Pothu Maruthuvam
Goverment Siddha Medical College and Hospital Palayamkottai.
Tirunelveli
TAMIL NADU |
8883955520
sasrajenthiran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ATTATHI CHOORANAM |
40mg/kg for three times/day A/F orally 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
I. Marital Status : Married / Unmarried
II. Symptoms
-Irregular menstruation, oligomenorrhoea (or) amenorrhoea (or) dysmenorrhoea (or) dysfunctional uterine bleeding
-Hirsuitism and obesity
III. Patient willing to take USG pelvis
IV. Patient willing to undergo routine blood investigation
V. USG pelvis showing polycystic ovaries
VI. Patient willing to participate in trial and signing in consent form
|
|
| ExclusionCriteria |
| Details |
I. History of recent hormone therapy (within one year)
II. Pregnancy.
III. Lactating mother.
IV. History of renal disease
V. History of Liver diseas
VI. Uterine anomalies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnosis of RAKTHA SOORAI VAAYU and evaluation of the therapeutic efficacy of Attathi chooranam. It is assessed by the improvement in the score of irregular menstruation (Intermenstrual period & duration of bleeding) before and after treatment. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the polycystic swellings of the ovaries in USG pelvis and reduction of other symptoms. |
48 days |
|
|
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)
|
14/05/2019 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a prospective open labelled, non-randomised, phase II clinical trial to determine the efficacy and safety of ATTATHI CHOORANAM in patients with RAKTHA SOORAI VAAYU ( POLY CYSTIC OVARIAN SYNDROME). The trial drug is processed from raw herbs and mineral. In this clinical trial to be held at GSMC, Palayamkottai, 40 patients (20 in OPD + 20 in IPD) will be recruited and the trial drug will be administered at the dose of 40 mg/ Kg/ BW TDS A/F along with Honey or ghee as adjuvant for a period of 48 days. All the study related data will be recorded and documented in a separate file for each patients. In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD, GSMC, Palayamkottai. During this trial all the efficacy and safety parameters will be recorded in the CRF. After completion of trial all the study related data will be analysed statistically. |