| CTRI Number |
CTRI/2020/08/027436 [Registered on: 28/08/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Shatpushpa taila Nasya and Shatpushpa Taila Matrabasti with Tilamooladi churan in the management of Pushpaghni wsr to Polycystic Ovarian Syndrome |
|
Scientific Title of Study
|
A comparative study of shatpushpa taila (nasya and matrabasti) along with tilamooladi churan in the managment of pushpaghni wsr to polycystic ovarian syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheeni sharma |
| Designation |
MD scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
UCA Jodhpur,karwar
Dsrrau jodhpur
UCA Jodhpur,Karwar
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7665885777 |
| Fax |
|
| Email |
sheenisharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Sharma |
| Designation |
Assistant Professor P.G Department of Prasuti Tantra evum Street Roga |
| Affiliation |
University College of Ayurveda,DSRRAU Jodhpur |
| Address |
Dr Sarvepalli RadhaKrishnan Ayurved University Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166607559 |
| Fax |
|
| Email |
vd_rashmi11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Sharma |
| Designation |
Assistant Professor P.G Department of Prasuti Tantra evum Street Roga |
| Affiliation |
University College of Ayurveda,DSRRAU Jodhpur |
| Address |
Dr Sarvepalli RadhaKrishnan Ayurved University Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166607559 |
| Fax |
|
| Email |
vd_rashmi11@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved university,Nagour Road Jodhpur |
| Type of Sponsor |
Government 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 |
| Dr Rashmi Sharma |
University College of Ayurveda |
DSRRAU Jodhpur
Jodhpur
RAJASTHAN |
9166607559
vd_rashmi11@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DSRRAU JODHPUR |
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 |
Shatpushpa taila Matrabasti along with tilamooladi churna |
Shatpushpa taila Matrabasti basti 60 ml once a day and Tilamooladi churna 5g twice a day for 7 days |
| Intervention |
Shatpushpa taila Nasya along with Tilamooladi churna |
Shatpushpa taila Nasya 2 drops in each nostril once a day and Tilamooladi churna 5g twice a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Fullfill at least 2 of the following:-
1.Oligomenorrhea and/or anovulation
2.Hyperandonism (Clinical and/or bio-chemical)
3.PCOS-Diagnosed by Trans Vaginal Sonography (TVS In married)and USG Abdomen in unmarried.
|
|
| ExclusionCriteria |
| Details |
•Any other cause of oligomenorrhea and anovulation excluding PCOD.
•Any organic lesion like adrenal or ovarian.
•Congenital anomalies and any other pelvic pathology.
•Patients having STDs |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in signs and symptoms of patients
Oligomenorrhea,Hypomenorrhea, Dysmenorrhoea,Menorrhagia
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy of the medicine on
Obesity,Acne, Hirsutism |
2 months |
|
|
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)
|
05/09/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomised controlled trial in which 15 Patients will receive Shatpushpa taila Nasya with tilamooladi churna and 15 Patients will receive Shatpushpa taila Matrabasti along with Tilamooladi Churna suffering form Polycystic Ovarian Syndrome |