| CTRI Number |
CTRI/2014/01/004282 [Registered on: 03/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
03/01/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical research study of Soothaga vaayu leghium and Veezhi ennei (Internal medicines)in the treatment of Garpa vaayu (polycystic ovarian disease) |
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Scientific Title of Study
|
Clinical study on Garpa vaayu (polycystic ovarian disease) and the drug of choice is Soothaga vaayu leghium and Veezhi ennei.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
C PRATHEEPA |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPT.OF MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8056903166 |
| Fax |
044-22381314 |
| Email |
pratheepa.bsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR K MANICKAVASAKAM |
| Designation |
DIRECTOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DIRECTOR
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
dr.kmvm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR H NALINI SOFIA |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPT.OF MARUTHUVAM (MEDICINE)
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9677777677 |
| Fax |
044-22411611 |
| Email |
dr.h.nalinisofia@gmail.com |
|
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Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL
|
|
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Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
NATIONALINSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
TAMILNADU
CHENNAI |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR C PRATHEEPA |
AYOTHIDOSS PANDITHAR HOSPITAL |
OPD NO:1, DEPT.OF MARUTHUVAM (MEDICINE),AYOTHIDOSS PANDITHAR HOSPITAL,NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU |
8056903166
044-22381314
pratheepa.bsms@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
GARPA VAAYU(POLYCYSTIC OVARIAN DISEASE), |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SOOTHAGA VAAYU LEGHIUM WITH VEEZHI ENNAI |
70 ml of VEEZHI ENNAI will be administered orally before food as a single dosage for the first three days of every menstrual cycle for the consecutive three cycles to induce purgation. In addition 6gm of SOOTHAGA VAAYU LEGHIUM will be administered orally twice a day after food for a period of 15 day in each menstrual cycle for the consecutive three cycles |
|
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
•Age: 16-35 years
•Patient having the symptoms of irregular menstruation
•Oligomenorrhoea (or) Amenorrhoea (or) Dysmenorrhoea
•Patient willing to take USG pelvis
•Patient willing to undergo routine blood investigation.
•USG pelvis showing polycystic ovaries
•Patient willing to undergo purgation as a preparatory part of treatment
•Patient willing to participate in trial and signing in consent form
|
|
| ExclusionCriteria |
| Details |
• H/O hypertension
• H/O diabetes mellitus
• H/O cardiac disease
• Pregnancy and lactation
• H/O thyroid dysfunction
• H/O recent hormone therapy (Past one year)
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| assessed by the improvement in the score of irregular menstruation (Intermenstrual period& duration of bleeding) |
pre study screening and after treatment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the polycystic swellings of the ovaries in USG pelvis and reduction of other clinical symptoms |
pre study screening and after treatment |
|
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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 3 |
|
Date of First Enrollment (India)
|
01/01/2014 |
| 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) |
Open to Recruitment |
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Publication Details
|
NONE YET |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
It is a single, non-randomized, open-label trial to determine the efficacy and safety of SOOTHAGA VAAYU LEGHIUM (Prepared with 22 herbal constituents and one mineral constituent, milk ghee and honey) and VEEZHI ENNAI (prepared with 15 herbal constituents and castor oil and ghee) in patients with Garpa vaayu (polycystic ovarian disease.) In this trial 40 patients will be recruited. 70 ml of Veezhi ennai will be administered orally before food as a single dosage for the first three days of every menstrual cycle for the consecutive three cycles to induce purgation. In addition 6 gm of Soothaga vaayu leghium will be administered orally twice a day after food for a period of 15 days in each menstrual cycle for the consecutive three cycles.During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety and efficacy parameters will be recorded in CRF.After completion of the trial all the study related data will be analysed statistically.The out come of the trial will be published in Indian Journal of Medical Research.
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