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Clinical Trials/CTRI/2024/01/061570
CTRI/2024/01/061570RecruitingPhase 1/2

An interventional study on dietetic etiology (Aharaja nidana) and efficacy of hetu vipareeta ahara in anovulation w.s.r to PCOS.

KLE Academy of Higher Education and Research1 site in 1 country60 target enrollmentStarted: January 27, 2024Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1/2
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Efficacy of Protein rich diet in inducing menstruation.

Study Overview

Brief Summary

Amenorrhea in PCOS is failure of
maturation and release of ovum into the uterine cavity and it is the major
diagnostic and must appear abnormality in PCOS patients.

Amenorrhea is resulted by abnormal hormonal secretions during menstruation cycle and can be co related to vandya yoni vyapat. Generally, in concern of etiology of anovulation we always talk about life style, environment, genes and organ dysfunction which interfere the ovulation process and we talk less about dietetic causes of Anovulation. Improper diet pattern is one among the prime life style issues. Mithya aachara is term coined for this improper life style in ayurveda science which even includes improper diet practices (Mithya Ahara).

Most of the women struggles to maintain fitness and nutrition due to unawareness about what to eat? Or how to eat? and always live a stressful life to complete their responsibilities whether she is student or house wife or laborer or professional.

So, in this study we are trying to rule out that which type of meals and diet pattern is mainly affecting the ovulation hormones majorly and resulting into anovulation.

This study will be intended to establish a chart Mithya ahara which are majorly causing Vandya yonivayapat or Anovulation and how hetu vipareeta aahara reverse the anovulation and regularize the ovulation in selected population.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Oliguria or Amenorrhea 2) Infertility 3) Weight gain 4) Acne vulgaris 5) Skin thickening and darkening at the nape of neck and inner thighs •Hirsutism.

Exclusion Criteria

  • •Any other systemic disorders like nutritional deficiency anemia, hepato-biliary diseases, cardiac diseases, pulmonary diseases etc.

Outcomes

Primary Outcomes

Efficacy of Protein rich diet in inducing menstruation.

Time Frame: 12 Weeks

Secondary Outcomes

  • Assessment of Causes & Risk factors for PCOS in terms of Food(12 Weeks)

Investigators

Sponsor
KLE Academy of Higher Education and Research
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Roopa Dodamani

Shri B M Kankanawadi Ayurveda Mahavidyalaya

Study Sites (1)

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