| CTRI Number |
CTRI/2017/10/010048 [Registered on: 09/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
combined effectiveness of ashoka valkala kshirapaka and mustaamruthadi kashaya in Asrigdara (Dysfunctional Uterine Bleeding) |
|
Scientific Title of Study
|
Clinical Evaluation Of Combined Effectiveness Of Ashoka Valkala Kshirapaka And Musthamruthadi Kashaya In Asrigdara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surya Santhosh C |
| Designation |
Second Year PG scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hassan |
| Address |
Dr Surya Santhosh C
Second Year Pg Scholar
Department Of Prasuti Tantra And Stri Roga
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
BM ROAD Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
8861767496 |
| Fax |
08172-256464 |
| Email |
drsuryasanthosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri Bhat N V |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Dr Gayathri Bhat N V
Professor
Department Of Prasuti Tantra And Stri Roga
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
BM ROAD Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
08172-256464 |
| Email |
gaya3hassan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Bhat N V |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Dr Gayathri Bhat N V
Professor
Department Of Prasuti Tantra And Stri Roga
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
BM ROAD Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
08172-256464 |
| Email |
gaya3hassan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharemasthala Manjunatheshwatra College of Ayurveda And Hospital
BM Road Thanniruhalla Hassan 573201
Karnataka India
sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201 Karnataka |
| 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 |
| Dr Surya Santhosh C |
Sri Dharmasthala Mnjunatheshwara College Of Ayurveda And Hospital Hassan |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital,
Opd No 16,Department of Prasuti Tantra and Stri Roga
B M Road Thanniruhalla Hassan 573201
Karnataka India
Hassan
KARNATAKA |
8861767496
08172-256464
sdmcah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionl Ethics committee,Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, B M Road Thanniruhalla , hassan-573201,Karnataka, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Asrigdara
Dysfunctional Uterine Bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashoka Valkala Kshirapaka And Musthamruthadi Kashaya |
Ashoka Valkala Kshirapaka
Ashoka Valkala Kshirapaka Will Be Given 96ml In Divided Dose Musthamruthadi Kashaya
Musthamruthadi Kashaya Will Be Given 15ml Kashaya Thrice Daily With Eaqual Quantity Of Water for 2 months |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients Aged Between 16 To 50 Years
Those Patients Who Are Ready To Sign Informed Consent Form
|
|
| ExclusionCriteria |
| Details |
UTRINE POLYP
CARCINOMA OF CERVIX
FIBROID UTERUS
COAGULATION DISORDERS
HYPOTHYROIDISM
THREATENED SPONTANEOUS INCOMPLETE ABORTION
ECTOPIC PREGNANCY
ISCHEMIC HEART DISEASE
DIABETES MELLITUS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment Of Parameters Will be done on Review on 15 days During treatment for 2 months and follow up after treatment for 1 month |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/02/2017 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
will be done in due course of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
need for study states that asrigdara is the most common gyaenecological problems faced by women during their active reproductive period which causessignificant discomfort and stress for the women as well as her family. for the diseases of yoni that to for asrigdara apana vata is consider as primary cause and it is said that without vitiation of vata, manifestation of yoni roga are not possible.in ayurveda we gets various treatment in the management of asrigdara namely swarasa, choorna etc.charaka acharya explained it to be treated on the lines of raktatisara, raktapitta and raktarsha. hence ashoka valkala khirapaka and musthamruthadi kashaya taken in the treatment for asrigdara.
Review of literature comprises of all the classical references regarding asrigdara the details of the drug along with botanical name part used and proportion has been explained along with the preparation method and method of administration of both the formulations.
Materials and methods gives an idea regarding source of data which will be 30 patients from inpatient and outpatient departments of sri dharmasthala manjunatheshwara college of ayurveda and hospital, hassan who fulfill the daignostic criteria,inclusion criteria where in patients suffering from asrigdara will be taken
next in plan of study, this is a exploratory single arm open labelled clinical trial at out patient department level.ashoka valkala kshirapaka and musthamrithadi kashaya will be advised orally for 30 days, patient asked to review after 15 days to know the patient condition as well as the drug action. Total duration of administration of ashoka valkala kshirapaka and musthamrithadi kashaya is 2 months and follow up for 1 month.during follow up study reduction in the severity,duration of symptoms will be assessed basing on scoring system. it will be analysed using appropriate statistical test.Demographic data and other relevant information will be analysed with descriptive statistics.
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