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Clinical Trials/CTRI/2024/10/074998
CTRI/2024/10/074998Not yet recruitingPhase 2/3

Clinical Study of Brimhana Basti and Shatavari Taila Nasya Karma In Asthikshaya with Special Reference to Post Menopausal Osteoporosis.

GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI1 site in 1 country60 target enrollmentStarted: October 20, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Effect on Osteoporosis

Study Overview

Brief Summary

This study is an Interventional Open and Randomized Controlled Clinical Trial where review of relevant literature from Ayurvedic classics, modern medical science, Journals, previous researches and internet in great depth for conceptualization of etio-pathogenesis of Asthikshaya w.s.r. to PostMenopausal Osteoporosis and probable mode of action of Ayurveda drugs and procedures are taken. Patients will be randomly selected from the OPD/IPD of Department of Panchakarma, Government PG Ayurveda College and Hospital, Varanasi. 60 Patients will be studied under 2 groups having 30 patients in each group. Group A- In this group each patient will be administered with Brimhana Basti for 30 days**.**

Group B- In this group each patient will be administered with Shatavari taila Nasya  for 30 days.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
50.00 Year(s) to 70.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Post menopausal females.
  • Patients presenting the classical symptoms of Asthi kshaya viz., Asthishool, Sandhi shaithilya, Asthi toda, Dourbalya, Sandhi shool, Asthi soushirya etc.
  • History of less than 1 yr.
  • •Patients voluntarily willing to participate in the trial.

Exclusion Criteria

  • •Patient not fitting in the criteria of Basti karm.
  • •Patients not fitting in the criteria of Nasya karm.
  • •History of other active inflammatory or rheumatic disease, gouty arthritis.
  • •Severe articular inflammation as confirmed by physical examination.
  • •Morbidity other than Asthi kshaya.
  • •Patient age below 50yrs, menstruating female.
  • •Patient with severe hematological and hepatic, renal disorders, tuberculosis.
  • •Patients of Autoimmune joint disorder.

Outcomes

Primary Outcomes

Effect on Osteoporosis

Time Frame: 30DAYS

Secondary Outcomes

  • To Increase the quality of life(30 DAYS)

Investigators

Sponsor
GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

DRNITIKA PRASAD

GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI

Study Sites (1)

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