| CTRI Number |
CTRI/2019/07/020066 [Registered on: 08/07/2019] Trial Registered Prospectively |
| Last Modified On: |
07/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Nitya Virechana(Purgation Therapy) and Uttarbasti on Intra Uterine Insemination |
|
Scientific Title of Study
|
Evaluation Of the Effect Of Nitya Virechana and Uttarbasti on Intra Uterine Insemination:A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Dixit |
| Designation |
PG scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room No. 405,Fourth Floor SRPT Department, Academic Block, All India Institute Of Ayurveda,Sarita Vihar, New Delhi
76, Shri Ram Nagar Colony,N.E.B. Housing Board, Alwar (Rajasthan)
New Delhi
DELHI
110076
India |
| Phone |
9462472371 |
| Fax |
|
| Email |
nehadixit0411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamini Dhiman |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room No. 402,Fourth Floor SRPT Department, Academic Block, All India Institute Of Ayurveda,Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
8920900968 |
| Fax |
|
| Email |
kd44ayu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha Dixit |
| Designation |
PG Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room No. 405,Fourth Floor SRPT Department, Academic Block, All India Institute Of Ayurveda,Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9462472371 |
| Fax |
|
| Email |
nehadixit0411@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute OF Ayurveda, Gautampuri, Sarita Vihar, Mathura Road,New Delhi-110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda, Sarita Vihar , New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dixit |
All India Institute Of Ayurveda |
OPD 201,Second Floor Stree Roga evum Prasuti Tantra Department, All India Institute Of Ayurveda, Sarita Vihar, New Delhi
South
DELHI |
9462472371
nehadixit0411@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: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dhanwanter Taila |
Uttar Basti given 3 days With 5 ml Dhanwanter taila For 3 cycles after cessation of Menses followed with Pre ovulatory and post ovulatory Intra Uterine Insemination |
| Intervention |
Eranda Sneha |
Eranda Sneha (Dose Decided after Pilot Study) Given 3 Months orally Followed with Preovulatory and Post ovulatory Intra Uterine Insemination |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Unexplained Infertility
Hostile Cervical Mucus
Male Factor involvement
Patients having history of Failed IUI and IVF |
|
| ExclusionCriteria |
| Details |
Anovulatory Cycle
Tubal Blockage
Anatomical Defect of Reproductive tract
Disorder of Reproductive Tract like Tuberculosis Carcinoma
Sexually Transmitted disease
Allergic or Sensitive to selective Procedure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conception |
9months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conception |
9 Months |
|
|
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)
|
15/07/2019 |
| 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="1"
Months="1"
Days="1" |
|
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
|
This study is a randomized, parallel group trial to evaluate the role of Nitya Virechana with Eranda Sneha and Uttarbasti with Dhanwantar Taila for 3 cycle after cessation of Menses in 40 patients of Unexplained Infertility that will be conducted in All India Institute of Ayurveda. Primary and Secondary both end point are the Conception in this study. |