| CTRI Number |
CTRI/2020/03/024169 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
18/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of prajasthapan ghan vati and prajasthapan tail uttarbasti in recurrent abortion |
|
Scientific Title of Study
|
Role of prajasthapan mahakashaya (p.s.m) ghan vati and prajasthapan mahakashaya tail siddha uttarbasti in putraghni yonivyapad (recurrent spontaneous abortion) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha gupta |
| Designation |
pg scholar |
| Affiliation |
rishikul campus uttarakhand ayurved university dehradun |
| Address |
Prasuti and stri rog vibhag Rishikul campus uttarakhand ayurved university dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8112333985 |
| Fax |
|
| Email |
gupta9012509363@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hem prakash |
| Designation |
Assistant professor |
| Affiliation |
rishikul campus uttarakhand ayurved university dehradun |
| Address |
Prasuti and stri rog vibhag Rishikul campus uttarakhand ayurved university dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8112333985 |
| Fax |
|
| Email |
hemprakash78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha gupta |
| Designation |
pg scholar |
| Affiliation |
rishikul campus uttarakhand ayurved university dehradun |
| Address |
Prasuti and stri rog vibhag Rishikul campus uttarakhand ayurved university dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8112333985 |
| Fax |
|
| Email |
gupta9012509363@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul campus uttarakhand ayurved university dehradun 249401 |
|
|
Primary Sponsor
|
| Name |
Neha gupta |
| Address |
Rishikul campus haridwar |
| 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 |
| Neha gupta |
Rishikul ayurveda hospital |
Prasuti and stree rog vibhag o.p.d no. 9.
Hardwar
UTTARANCHAL |
8112333985
gupta9012509363@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O039||Complete or unspecified spontaneous abortion without complication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
nil |
| Intervention |
Prajasthapan mahakashaya ghan vati and prajasthapan mahakashaya siddh tail |
prajasthapan mahakashaya ghan vati 500mg t.d.s with cow milk and prajasthapan mahakashaya siddha tail 3-5ml uttar basti for 7day in a month after cesseation of menses for 3 month. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
2 or more spontaneous abortion before 20 weeks of pregnancy,pateint having TORCH test positive also included. |
|
| ExclusionCriteria |
| Details |
Those having induced abortion,having chromosomal disorder,having congenital malformation and abnormal placentation,abortion with fetal anomaly,having immunological disorder,sytemic diseases,bleeding disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Continuations of pregnancy upto 9 month,delivery of healthy baby. |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Continuations of pregnancy upto 9 month, delivery of a healthy baby. |
3month |
|
|
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 |
|
Date of First Enrollment (India)
|
24/03/2020 |
| 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="0"
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)?
|
|
Brief Summary
|
In ayurvedic classics gynecological disorders are described in yonivyapad which are 20 in number. Putraghni yonivyapad is one of them and most of its symptoms resembles with recurrent spontaneous abortion. Most studies demonstrate a spontaneous miscarriage rate of 10-15%; of which 80% spontaneous abortion occur during second and third month of pregnancy. Due to limitation of medical therapy (Hcg, corticosteroids, etc for continuation of pregnancy) as well as complication of surgical treatment (i.v.f) of modern science there is a necessity to find out a harmless and cost effective therapy to manage the condition. In ayurveda, prajasthapan mahakashaya is mentioned as garbhastapan gana.These drugs help to establish garbh by working on their causative factor, resulting in continuation of pregnancy upto term. Present study is an effort to find out the effect of these ayurvedic drugs in recurrent spontaneous abortion, so that a cost effective and fruitful treatment can be provided. |