| CTRI Number |
CTRI/2021/05/033360 [Registered on: 04/05/2021] Trial Registered Prospectively |
| Last Modified On: |
03/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the role of Eladi Kwatha with Sharkara and Madhu in atyadhik yonigata raktastrava with special reference to Abnormal uterine bleeding |
|
Scientific Title of Study
|
An open label single arm clinical study of Eladi Kwatha with Sharkara and Madhu in Yonipravaha with special reference to Abnormal 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 |
Dr Kalyani Mitalkumar Mahajan |
| Designation |
PG scholar |
| Affiliation |
SGAK Hospital Hadapsar Pune 411028 |
| Address |
Sane Guruji Arogya kendra PG girls hostel, room no 222 Malwadi Hadapsar Pune
Deptartment of striroga prasutitantra Sumatibhai Shah Ayurved Mahavidyalaya Malawadi Hadapsar Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
08983460329 |
| Fax |
|
| Email |
mkrushna002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Kalyan Gawade |
| Designation |
Assistant Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Deptartment of striroga evum prasutitantra Sumatibhai Shah Ayurved Mahavidyalaya Malawadi Hadapsar Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9881840224 |
| Fax |
|
| Email |
truptigawade13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trupti Kalyan Gawade |
| Designation |
Assistant Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Deptartment of striroga prasutitantra Sumatibhai Shah Ayurved Mahavidyalaya Malawadi Hadapsar Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9881840224 |
| Fax |
|
| Email |
truptigawade13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of striroga and prasutitantra sane Guruji Arogya Kendra Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Kalyani Mitalkumar Mahajan |
| Address |
PG Girls Hostels, room no 222 Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Department of striroga and prasutitantra sane Guruji Arogya Kendra Hadapsar Pune 411028 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kalyani Mitalkumar Mahajan |
Sane Guruji Arogya Kendra |
Department of striroga and prasutitantra Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA |
8983460329
mkrushna002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E349||Endocrine disorder, unspecified. Ayurveda Condition: Yonipravaha (Abnormal Uterine Bleeding), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eladi Kwatha With Sharkara and Madhu |
will be given 20ml four times a day for 5 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients between the age group 15-45 yrs
Both married and unmarried women
Patients having Abnormal Uterine Bleeding with excessive and prolonged menstrual bleeding
|
|
| ExclusionCriteria |
| Details |
Patients taking anti coagulation therapy and having any coagulation
defect.
Patients with severe malnutrition and severe anemia (Hb ≤ 8 gm/dl).
Threatened, spontaneous or incomplete abortion/ectopic pregnancy,
trophoblastic diseases, placental abnormalities and Antepartum
Hemorrhage.
Patients with systemic diseases like uncontrolled D.M. and T.B.
History of documented vascular disease like coronary artery disease,
cerebrovascular disease or stroke, transient ischemic attack, peripheral
vascular disease and DVT.
Condition like endometrial cancer of cervix, etc.
Bleeding from Reproductive Track due to traumatic causes, motor vehicle
accident and IC |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Eladi Kwatha with Sharkara and Madhu in
Yonipravaha.
|
day 1 to day 5 of Abnormal uterine bleeding |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse effect of drug Eladi Kwatha with Sharkara and Madhu will be
observed during clinical study, if any. |
18 months of study period |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not any |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE - An open label single arm clinical study of Eladi Kwatha with Sharkara and Madhu in Yonipravaha with special reference to abnormal uterine bleeding Study design - an open label single arm clinical study SAMPLE SIZE - 30 SAMPLING METHOD - Sequential Sampling
INCLUSION CLITERIA -Patients between the age group 15-45 yrs Both married and unmarried women Patients having Abnormal Uterine Bleeding with excessive and prolonged menstrual bleeding
EXCLUSION CLITERIA - Patients taking anti coagulation therapy and having any coagulation defect. Patients with severe malnutrition and severe anemia (Hb ≤ 8 gm/dl). Threatened, spontaneous or incomplete abortion/ectopic pregnancy, trophoblastic diseases, placental abnormalities and Antepartum Hemorrhage. Patients with systemic diseases like uncontrolled D.M. and T.B. History of documented vascular disease like coronary artery disease, cerebrovascular disease or stroke, transient ischemic attack, peripheral vascular disease and DVT. Condition like endometrial cancer of cervix, etc. Bleeding from Reproductive Track due to traumatic causes, motor vehicle accident and IC
WITHDRAWAL CLITERIA - Patients not willing for further trial. - If patient develops any adverse effect. - If bleeding increases during trial. |