Single Blind Clinical Study of Shodhana Karma and an indigenous Drug Combination on Polycystic Ovarian Disease

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/12/007523
• Date of registration: 02-12-2016
• Prospective Registration: No
• Primary sponsor: Rajiv Gandhi University of Health Sciences Karnataka
• Public title: Single Blind Clinical Study of Shodhana Karma and an indigenous Drug Combination on Polycystic Ovarian Disease
• Scientific title: Single Blind Clinical Study of Shodhana Karma and an indigenous Drug Combination on Polycystic Ovarian Disease - PCOD
• Date of first enrolment: 01-04-2016
• Target sample size: 100
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13698
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Mamatha
• Affiliation: SDM College of Ayurveda and Hospital Kuthpady

• Name: Dr Mamatha
• Affiliation: SDM College of Ayurveda and Hospital Kuthpady

Key inclusion & exclusion criteria

Inclusion criteria: PCOD with hypothyroidism

PCOD with infertility

PCOD with menstrual irregularity

Diagnostic cases of PCOD with the help of ultrasonography and hormonal assay


Exclusion criteria: Cases of obesity other than PCOD

Ammenorrhoea due to pregnancy, genital tuberculosis and premature ovarian failure

PCOD cases with severe systemic illness



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Diagnostic cases of PCOD

Intervention(s)

Intervention1: Asanadi gana quata,kanchanaraguggulu and shatapushpa churna: Asanadi gana quata and kanchanaraguggulu having the property of kapha meda haratwa, being indicated in granti and prameha, shatapushpa churna act as vyadhi pratyaneeka chikitsa in the said disorder and hence they are administered in all kinds of presentations of the patients
Intervention2: Asanadi gana quata, Kanchanaraguggulu and shatapushpa churna
: Asanadi gana quata 50 ml twice a day orally for 6 months
and Kanchanara guggulu 2 tablet twice a day orally for 6 months and
Shatapushpa churna 5 gm twice a day orally for 6 months
Control Intervention1: No: No comparator agent used in the study

Primary Outcome(s)

Regularization of menstrual cycle

Conception in eligible infertile couple

Normalization of PCOD findings in ultrasonography and hormonal assay

Timepoint: Regularization of menstrual cycle

Conception in eligible infertile couple

Normalization of PCOD findings in ultrasonography and hormonal assay

Secondary Outcome(s)

Regularization of menstrual cycle

Conception in eligible infertile couple

Normalization of PCOD findings in ultrasonography and hormonal assay

Timepoint: 6 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Ayurveda formulations

Secondary Sponsor(s)

Department of AYUSH

Ethics review

Status: Approved
Approval date: 03/12/2015
Contact:

IEC-Human