| CTRI Number |
CTRI/2023/03/050293 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Shaliparnyadi Yusha in Garbhini Parshwagraha (Rigidity in flanks associated with lower back pain) in Second and Third Trimester |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Shaliparnyadi Yusha in Garbhini Parshwagraha (Rigidity in flanks associated with lower back pain) in Second and Third Trimester |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NEHA SAIN |
| Designation |
MS Streerog Evam Prasutitantra |
| Affiliation |
DR D Y Patil college of ayurveda and research centre pimpri pune |
| Address |
OPD No 2 Streerog Evam Prasutitantra Dr D Y Patil College of Ayurveda and Research Centre Pimpri Pune 18 Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9466214039 |
| Fax |
|
| Email |
nehusain16111995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Jayashree Patil |
| Designation |
HOD and Professor |
| Affiliation |
DR D Y Patil college of ayurveda and research centre pimpri pune |
| Address |
OPD No 2 Streeroga Evam Prasutitantra Dr D Y Patil College of Ayurveda and Research Centre Pimpri Pune 18 Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree Patil |
| Designation |
HOD And Professor |
| Affiliation |
DR.D.Y Patil college of ayurveda and research centre pimpri pune |
| Address |
OPD No 02 Streerog evam prasutitantra DR.D.Y Patil college of ayurveda and research centre pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y Patil college of ayurveda and research centre pimpri pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Neha Sain |
| Address |
DR D Y Patil college of ayurveda and research centre pimpri pune 411018 |
| 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 NEHA SAIN |
DR D Y PATIL COLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPRI PUNE 18 |
OPD NO 2 STREEROGA & PRASUTITANTRA DR D Y PATIL COLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPRI PUNE 18 INDIA
Pune
MAHARASHTRA |
9466214039
nehusain16111995@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:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHALIPARNYADI , Reference: KASHYAP, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1Garbhini of second and third trimester 2 Garbhini suffering from symptoms such as rigidity in flanks ( Parshwagraha ) lower back pain of varying intensity |
|
| ExclusionCriteria |
| Details |
1 Pregnant patient daignosed with orthopaedic deformity such as scoliosis
2 Pregnant female having any congenital anomaly
3 Renal cholic pain |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the efficacy of Shaliparnyadi Yusha in Garbhini Parshwagraha (Rigidity in flanks associated with lower backpain) in Second and Third Trimester |
Follow up will be taken on 7th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the other effects of Shaliparnyadi Yusha in Garbhini |
Follow up will be taken on 7th and 15th day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/03/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1 This is a single arm clinical study 2 The aim of study is to evaluate the efficacy of Shaliparnyadi Yusha in Garbhini Parshwagraha (Rigidity in flanks associated with lower back pain ) in Second and Third Trimester 3 Total 32 patients will be enrolled and approximately 5gm (1 sachet) of this Yusha will be provided in OD dose in morning empty stomach |