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Clinical Trials/CTRI/2025/04/083816
CTRI/2025/04/083816RecruitingPhase 2

Efficacy Of Krishnatiladi Kashyam Ghanvati As Artava Janan (Mensturation) In Patients Of Avrita Vata Artava Dushti WSR PCOS (Phenotype D)

The Central Council for Research in Ayurvedic Science1 site in 1 country30 target enrollmentStarted: April 9, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Krishnatiladi kashayam ghanvati may act as emmenogogue

Study Overview

Brief Summary

Polycystic Ovarian Syndrome is a most common metabolic and endocrine disorder in women of reproductive age It affects an estimated 5 to13 percent females and up to 70 percent of women with PCOS worldwide remains undiagnosed  Symptoms of PCOS include Amenorrhea or infrequent menstruation irregular bleeding and infrequent or no ovulation and multiple immature follicles. Later complication of PCOS is associated with type 2 diabetes  heart disease and ovarian cyst. According to the Rotterdam consensus  PCOS is determined by the presence of at least two out of three of the following features: evidence of oligomenorrhea (cycles  greater than 35 days apart or less than 8 cycles per year) or anovulation or biochemical or clinical hyperandrogenism and Polycystic ovarian morphology  greater than or equal to 12 follicles measuring  two to nine  mm in diameter and or an ovarian volume greater than10 mL in at least one ovary) . Phenotype D  oligomenorrhoea / anovulation and PCOS without Clinical or biochemical hyperandrogenism. In Ayurvedic literature details as per PCOS is not described.  It is a syndrome involving Pitta and  Kapha  and Rasa dhatu Dushti Dhatwagni mandya and Artava Dushti.    It has been mentioned  in   Yogaratnakar Yonivyapchikitsa Adhyaya that after the use of decoction prepared from Krishna Tila (Sesame indicum Linn) Shelu (Cordia dichotoma Forst) and Karvi (Nigella sativa Linn) mensuration will start in three days. Krishna tila and Karvi is having Ushna Veerya these drug may initiate mensuration. So this study may evaluate the efficacy of KrishnaTiladikashayam  in dosage form of ghanvati  as artavajanan (emmenagogue). It may be more feasible dosage form for artavajanan on the PCOS (Phenotype D ) patients.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
16.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • patients having symptoms of PCOS phenotype D (oligomenorrhoea or anovulation and PCOS without Clinical or biochemical hyperandrogenism) 2 Artava kshaya and Amenorrhea or oligomenorrhea (cycles greater than 35 days apart or less than 8 cycles per year).
  • 3 Endometrial thickness is greater than 5mm in ultrasonography.

Exclusion Criteria

  • Female patients having any other disease causing oligomenorrhoea and anovulation excluding PCOD on the above criteria.
  • Known case of adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, cushing’s syndrome will be excluded.

Outcomes

Primary Outcomes

Krishnatiladi kashayam ghanvati may act as emmenogogue

Time Frame: baseline 7th day and 15th day of both menstrual cycle

Secondary Outcomes

  • Improvement In Symptoms Of PCOS(Amount Of Menstrual Flow Duration of Menstrual Bleeding)

Investigators

Sponsor
The Central Council for Research in Ayurvedic Science
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Dr. Shalini Varshney

Ayurvedic And Unani Tibbia College And Hospital

Study Sites (1)

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