A clinical trial to test the safety and effectiveness of combination therapy of 2 Ayurvedic products from Jammi Pharmaceuticals for treating women with PCOS

Phase 3

Completed

Conditions: Polycystic ovarian syndrome. Ayurveda Condition: PCOS,

Registration Number: CTRI/2021/07/034951

Lead Sponsor: Jammi Pharmaceuticals Pvt Ltd

Brief Summary: The polycystic ovarian syndrome commonly known as PCOS is a condition that is common among women of reproductive age. In PCOS many small cysts which are sacs filled with fluids grow inside the ovaries. The common features of PCOS are high levels of the male hormone androgen, irregular periods, lack of ovulation which alters the level of estrogen and progesterone.

NDTV health matters on January 5th,2018 reported that 1in 5women in their productive age in India suffer from PCOS. â€œThe exact cause of (PCOS) is unknown. It is a multifactorial metabolic disorder. In this syndrome, a combination of genetics, diet, lifestyle, and environment lead to hormonal disturbances which are responsible for the symptoms of PCOS,â€ says Dr. Shishta Nadda Basu, Senior Director and Head of Department, Obstetrics and Gynecology & IVF, Max Speciality Hospital, Shalimar Bagh, New Delhi.

Apart from irregular periods people with PCOS gain weight, grow facial hair, develop acne, and have infertility issues. Insulin resistance is a common problem in PCOS and if left unchecked can lead to type 2 diabetes.

PCOS is diagnosed through an ultrasound or by testing for hormones like follicle-stimulating hormones, estrogen levels, and luteinizing hormones. There is no definitive cure for PCOS in allopathy. The condition is managed by hormone therapy which has uncomfortable side effects.

Ayurveda has the cure for PCOS. Our Ayurvedic formulation CystEvit helps in evicting the cysts from the ovaries and Suventris helps regulate the hormonal balance. Our preliminary study of CystEvit and Suventris has demonstrated that CystEvit reduces the size and number of cysts and ensures ejection of Ova by improving ovulatory function. CystEvit also helps decrease androgenic features like hirsutism, acne, and alopecia.

This study is designed to evaluate the efficacy and safety of Suventris syrup and CystEvit Tablets in adult women diagnosed with Poly-Cystic Ovarian Syndrome.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 60

Inclusion Criteria

1.Young women of age between 18 to 40 yrs.
diagnosed withPCOS 2.Sub-fertilefemales 3.Polycystic ovaries with exclusion of otheraetiologies 4.Women with normal uterinecavity 5.Subjects with history of Impaired Glucose Tolerance or Insulin Resistance with PCOS 6.Normal physical activity confirmed with physical and clinical examination, and routine laboratory tests, including AST, ALT, haematology routine urinalysis and measurement of oral temperature and vitalsigns.

Exclusion Criteria

1.Pregnant or lactatingwomen.
2.Subjects with presence of infertility factors other thananovulation 3.Subjectswithpelvicorganicpathologies,presenceofotherpathologiessuchasnon- classical congenital adrenal hyperplasia, Cushingâ€™s syndrome and androgen secretingtumours 4.Subjects with thyroid dysfunction, hyperprolactenemia, androgen secreting neoplasia.
5.Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs, or other hormonaldrugs.
6.Subjects with any neoplastic, metabolic, and cardiovascular disorder or other concurrent medical illness (i.e., type 1 or type 2 diabetes, renal disease, and mal- absorptivedisorders,acuteandchronicinflammations)confirmedbasedonmedical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count andurinalysis.
7.Subjects with known history of hypersensitivity to the studydrugs.
8.Alcoholic consumers andsmokers.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â€¢To evaluate the efficacy of Suventris Syrup and CystEvit Tablet combination therapy when compared to standard of care in eviction of ovarian cysts in subjects diagnosed with Poly-Cystic OvarianSyndrome	120 days

Secondary Outcome Measures

Name	Time	Method
â€¢To evaluate the number of subjects showing normal ovulation after Suventris Syrup and CystEvit Tablets combination therapy when compared to stand ofcare.	120 days

Trial Locations

Locations (1): Udhbhava Hospital
🇮🇳
Bangalore, KARNATAKA, India
Udhbhava Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Hemalatha K
Principal investigator
9742797117
crudhbhava01@gmail.com