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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2017/04/008387
Date of registration: 21-04-2017
Prospective Registration: Yes
Primary sponsor: National institute of Ayurveda
Public title: A clinical trial in the management of female primary infertility
Scientific title: A comparative clinical study on the role of Virechana and Uttar basti, along with Yoga basti in the management of Vandhyatva with special reference to female infertility
Date of first enrolment: 01-05-2017
Target sample size: 30
Recruitment status: Completed
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18482
Study type:  Interventional
Study design:  Randomized, Parallel Group Trial
Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Open Label
 
Phase:  Phase 2/ Phase 3
Countries of recruitment
India
Contacts
Name: Dr Archana Kushwaha   
Address:  Department of Panchakarma, National institute of Ayurveda Jaipur 302002 Jaipur, RAJASTHAN India
Telephone: 8739860237
Email: sarveshksingh21@gmail.com
Affiliation:  National institute of Ayurveda Jaipur
Name: Dr Sarvesh Kumar Singh   
Address:  Department of Panchakarma, National institute of Ayurveda Jaipur P.G.Department of Panchakarma, National institute of Ayurveda,Jorawar singh gate, Jaipur 302002 Jaipur, RAJASTHAN India
Telephone: 8739860237
Email: sarveshksingh21@gmail.com
Affiliation:  National institute of Ayurveda Jaipur
Key inclusion & exclusion criteria
Inclusion criteria: (1) All cases of infertility.

(2) Age group between 18 to 40 years.

(3) Male counterpart should be normal in all aspects.

(4) Infertility due to PCOD.

(5) Infertility due to cervical factors.

(6)One fallopian tube must be patent.


Exclusion criteria: (1)Surgical factors including fibroid uterus, cervical polyp, cervical stenosis etc.

(2)Congenital anatomical defect.

(3)Patient suffering from severe infection or chronic systemic diseases, malignancy.

(4)Infertility due to tubal factors (if both tubes are block).

(5)Infertility due to peritoneal factors.

(6)Patient not suitable for Virechana, Asthapana basti and Uttar basti.



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Primary infertility
Intervention(s)
Intervention1: Erandamooladi yoga basti and Uttar basti from 4/5 day of menstrual cycle with Bala taila.: In this group Erandamooladi yoga basti will be given from 21st day of menstrual cycle and it wiil be followed by Uttar basti from 4/5 day of menstrual cycle with Bala taila.
Control Intervention1: Classical Virechana karma (Sneha virechana) with Tilvak ghrit followed by Erandmooladi Yoga basti: In this group Virechan Karma will be done with Tilvak ghrit and it will be followed by Erandmooladi yoga basti from 18th day of menstrual cycle.
Primary Outcome(s)
conceptionTimepoint: 2 months
Secondary Outcome(s)
Symptoms related with pregnancyTimepoint: 9 months
Secondary ID(s)
NIL
Source(s) of Monetary Support
National institute of Ayurveda,Jorawar Singh Gate,Amber road, Jaipur 302002
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 26/05/2016
Contact:
Institutional ethicas committe National institute of Ayurveda Jaipur
Results
Results available:
Date Posted:
Date Completed:
URL:
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