| CTRI Number |
CTRI/2019/06/019814 [Registered on: 21/06/2019] Trial Registered Prospectively |
| Last Modified On: |
21/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pipplyadi Taila Matra Basti And Varunadi Kwatha Oral Administration In Polycyctic Ovarian Disease |
|
Scientific Title of Study
|
AN OPEN LABEL SINGLE ARM CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF PIPPLAYADI TAILA MATRA BASTI AND VARUNADI KWATHA ORAL ADMINISTRATION IN THE MANAGEMENT OF POLYCYSTIC OVARIAN DISEASE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr CHAITHRA DM |
| Designation |
PG SCHOLAR |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Sdm College Of Ayurveda And Hospital Thannerhalla B M Road Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8618862147 |
| Fax |
|
| Email |
pg17120@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri Bhat N V |
| Designation |
MD |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Sdm College Of Ayurveda And Hospital Thannerhalla B M Road Hassan 573201
Sdm College Of Ayurveda And Hospital Thannerhalla B M Road Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
|
| Email |
drgayathribhat@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHAITHRA DM |
| Designation |
PG SCHOLAR |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
SDM COLLEGE OF AYURVEDA AND HOSPITAL THANNERHALLA B M ROAD HASSAN 573201
SDM COLLEGE OF AYURVEDA AND HOSPITAL THANNERHALLA B M ROAD HASSAN 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8618862147 |
| Fax |
|
| Email |
pg17120@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| SDM college of ayurveda and hospital Hassan |
|
|
Primary Sponsor
|
| Name |
Dr Chaithra DM |
| Address |
Sdm college of Ayurveda And Hospital BM Road Thanniruhalla Hassan 573201 |
| Type of Sponsor |
Other [Private 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 |
| Chaithra DM |
SDM COLLEGE |
Out Patient Department And In Patient Department of Prasooti tantra And Stree roga
OPD NO 16
Hassan
KARNATAKA |
8618862147
pg17120@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
Not applicale |
Not applicable |
| Intervention |
SINGLE GROUP |
PIPPLYADI TAILA
Route rectal
Dose 72 ml
Frequency of administration 2 cycles
VARUNADI KWATHA
15 Ml with 15 ml Luke warm water Before food for 18 days for 2 cycles . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Subjects willing to participate in study and sign the consent
age group of females ranging from 18 to 35 years
married and unmaaried females
subject complaining of menstrual irregularity oigomenorrhoea secondary ammenorrhoea and anovulation
subjects with usg findings of unilateral or bilateral polycystic ovaries
duration of PCOD less than 5 years |
|
| ExclusionCriteria |
| Details |
subject suffering from menorrhagia adrenal hyperplasia androgen secreting neoplasm cushing syndrome
any organic lesion of reproductive tract like tuberculosis carcinoma and congenital deformities of any pelvic pathology uterine fibroids
subject with benign or malignant lesion of uterus and ovaries
HIV HBSAg VDRL positive subjects
subject diagnosed with Diabetes mellitus type 2 hypertension thyroid dysfunction |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| presence or absence of cyst |
4 th month of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction of volume of both ovaries |
4 th month of treatment |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/06/2019 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open label single arm clinical study to evaluate the combined effect of pippalyadi taila matra basti and varunadi kwatha oral administration in the management of polycystic ovarian disease involving female of age 18 to 35 years who will be screened for PCOD and 2 cycles of matra basti and varunadi kashaya will be given and assesed for volume of both ovaries and presence or absence of cyst before and after treatment . |