| CTRI Number |
CTRI/2019/05/018981 [Registered on: 07/05/2019] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assess efficacy of Tiktaka ghrita enema & Dhtaki-Pugi kashaya in excessive uterine bleeding patients |
|
Scientific Title of Study
|
OPEN LABEL SINGLE ARM CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF TIKTAKA GHRITA MATRAVASTI & DHATAKI-PUGI KASHAYA IN ASRIGDARA (DYSFUNCTIONAL UTERINE BLEEDING) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asha Lekshmi N |
| Designation |
Dept.of Striroga &Prasuti Tantra, 2 nd Year PG scholar,Amrita School Of Ayurveda |
| Affiliation |
Amrita School Of Ayurveda,Amrita Vishwa Vidyapeetham,Amritapuri,Kollam |
| Address |
Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham,Amritapuri,Kollam
Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham,Amritapuri,kollam
Kollam
KERALA
690526
India |
| Phone |
8304076245 |
| Fax |
|
| Email |
lekshmiasha90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShaithya Raj |
| Designation |
Associate Professor,Dept.of Striroga &Prasuti Tantra,Amrita School Of Ayurveda |
| Affiliation |
Amrita School Of Ayurveda,Amrita Vishwa Vidyapeetham,Amritapuri,Kollam |
| Address |
Amrita School Of Ayurveda
Amrita Vishwa vidyapeetham,Amritapuri,kollam
Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham,Amritapuri,Kollam
Kollam
KERALA
690526
India |
| Phone |
8075599587 |
| Fax |
|
| Email |
shaithya.raj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asha Lekshmi N |
| Designation |
Dept.of Striroga &Prasuti Tantra,2 nd Year PG scholar,Amrita School Of Ayurveda |
| Affiliation |
Amrita School Of Ayurveda,Amrita Vishwa Vidyapeetham,Amritapuri,Kollam |
| Address |
Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham,Amritapuri,Kollam
Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham,Amritapuri,Kollam
Kollam
KERALA
690526
India |
| Phone |
8304076245 |
| Fax |
|
| Email |
lekshmiasha90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Life Ayurvedic Healthcare Vavvakavu Vallikavu Road via Pulinilkkumkotta, Vallikavu,kollam, Kerala 690546 |
| Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham
Vavvakavu Vallikavu Road via Pulinilkkumkotta, Vallikavu,kollam, Kerala 690546 |
|
|
Primary Sponsor
|
| Name |
Amrita School Of ayurveda |
| Address |
Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham
Amritapuri,Kollam |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Asha Lekshmi N |
Amrita School Of Ayurveda |
1 St floor,Dept.Of striroga &Prasuti Tantra, Amrita School of Ayurveda
Kollam
KERALA |
8304076245
lekshmiasha90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AIMS-2018-AYUR-252 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N99-N99||Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified, (2) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
woodfordia fructicosaflower
Areca catechu flower |
Tiktakaghrita matravasti 72 ml for 7 days
woodfordia fructicosa flower
areca catechu flower decoction 48 ml twice daily for 7 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients with age group 16-45 yrs.
2 Patients complaining with excessive bleeding /Prolonged bleeding/ / intermenstrual bleeding with increased amount (>80 ml) No. of pads (>4 pads/day) & duration (> 7 days) for at least previous three consecutive cycles
|
|
| ExclusionCriteria |
| Details |
1 Pregnancy & Abortion, PPH, IUCD insertion
2 Hb < 9 gm%
3 Known case of DM, HTN, Renal diseases, Liver Diseases, Cardiac diseases
Von-Willebrand’s disease & other bleeding diseases.
4 Known case of organic & pelvic pathology as per Ultrasonography report.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Amount of bleeding
|
After 7th day of menstruation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of Clots |
After 7 th day of menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/05/2019 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
open label singlearm clinical study to evaluate the effect of Tiktakaghrita matravasti & Dhataki-pugi kashaya in asrigdara (Dysfunctional Uterine Bleeding). For this study 30 patients attending the striroga & prasuti tantra OPD&IPD of Amrita School Of Ayurveda fullfilling the inclusion criteria will be recruited for study.The primary data for inclusion will be collected using proper history taking,pictorial blood assessment chart,USG & Blood routine examination.Medicine tiktaka ghrita purchased & it is used for matravasti 72 ml followed by internal administration of 48 ml fresh Dhataki pugi kashayatwice dailyfor 7 days.Procedure will be started only after 7 th day f menstruation,if the bleeding is not controlled with other oral medication.The assessment of blood loss is done through the pictorial blood assessment chart during each day of treatment. |