| CTRI Number |
CTRI/2021/01/030504 [Registered on: 15/01/2021] Trial Registered Prospectively |
| Last Modified On: |
09/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the Effect of trivrutadi oil matra basti (anal route administration of 60ml oil)in dysmenorrhea. |
|
Scientific Title of Study
|
A clinical study to Evaluate the Effect of trivritadi tail matra basti in udavartini yonivyapada (kashtartava) (primary dysmenorrhea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shobhna Shrivastava |
| Designation |
MS Scholar |
| Affiliation |
Dr. D. Y patil ayurvedic college and Research Centre Pimpri Colony pimpri-chinchwad |
| Address |
STREE rog PRASUTI TANTRA DEPARTMENT
Dr. D. Y patil ayurvedic college and research institute
Sant Tukaram Nagar, Pimpri, pune
STREE rog PRASUTI TANTRA DEPARTMENT
Dr. D. Y patil ayurvedic college and research institute
Sant Tukaram Nagar, Pimpri, pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7985366195 |
| Fax |
|
| Email |
steel.d.world@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayshree patil |
| Designation |
HOD , stree Rog prasuti tantra |
| Affiliation |
Dr. D. Y patil ayurvedic college and research institute, Pimpri pune |
| Address |
Street rog prasuti tantra department
Dr D Y Patil College Of Ayurveda And Research Center Sant
Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India
STREE rog PRASUTI TANTRA DEPARTMENT
Dr. D. Y patil ayurvedic college and research institute
Sant Tukaram Nagar, Pimpri, pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayshree patil |
| Designation |
HOD , stree Rog prasuti tantra |
| Affiliation |
Dr. D. Y patil ayurvedic college and research institute, Pimpri pune |
| Address |
STREE rog prasuti tantra department
Dr D Y Patil College Of Ayurveda And Research Center Sant
Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India
STREE rog PRASUTI TANTRA DEPARTMENT
Dr. D. Y patil ayurvedic college and research institute
Sant Tukaram Nagar, Pimpri, pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd and Ipd of stree Rog prasuti tantra department of Dr D.Y patil ayurvedic college and research institute Pimpri Pune. |
|
|
Primary Sponsor
|
| Name |
DrShobhna Shrivastava |
| Address |
Dr DY patil college of Ayurveda and Research Centre Sant Tukaram Nagar pimpri pune |
| Type of Sponsor |
Other [] |
|
|
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 |
| Shobhna Shrivastava |
dr. D.Y patil ayurvedic college and research institute Pimpri pune |
OPD NO.2 STREE ROG PRASUTI TANTRA DEPARTMENT
IPD stree rog prasuti tantra
department
Dr D. Y patil ayurvedic college and research institute Pimpri Pune
Pune
MAHARASHTRA |
7985366195
steel.d.world@gmail.com |
|
|
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:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Trivritadi tail matra basti |
Trivritadi tail matra basti will be given to females from menarche to nulliparous having complain of dysmenorrhoea 7 days before the onset of menstruation for 3 consecutive cycles. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Menarche to nuliiparous
Married unmarried both will be included. |
|
| ExclusionCriteria |
| Details |
Secondary dysmenorrhea
Patient with Parity 1
Pcod, std
Associated with other systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Trivritadi tail matra basti effective in kashtartava.
|
3 consecutive cycles
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of Study is to see the Effectiveness of Trivritadi tail matra basti in management of kashtartava (primary dysmenorrhea). The study will be conducted with 50 patient showing sings and symptoms of kashtartava in females (menarche to nuliiparous). 60 ml oil will be administered through anal route 7 days before the probable date of Menstruation for 3 consecutive cycles.
|