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

A PROSPECTIVE, OPEN-LABELLED, PROOF-OF-CONCEPT, COMPARATIVE CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE COMBINATION THERAPY OF SUVENTRIS SYRUP AND CYSTEVITTABLETS COMPARED WITH STANDARD OF CARE IN ADULT WOMEN DIAGNOSED WITH POLY-CYSTIC OVARIAN SYNDROME

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034951

Enrollment

Registered

2021-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: CystEvit and Suventris: CystEvit- 2 tablets- thrice daily after food Suventris- Syrup- 10ml twice daily after food Both the interventions work in Tande to reduce the symptoms of PCOS a

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Pregnant or lactatingwomen. 2. Subjects with presence of infertility factors other thananovulation 3. Subjectswithpelvicorganicpathologies,presenceofotherpathologiessuchasnon- classical congenital adrenal hyperplasia, Cushing’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

Design outcomes

Primary

Measure	Time frame
•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 OvarianSyndromeTimepoint: 120 days	—

Secondary

Measure	Time frame
• To evaluate the number of subjects showing normal ovulation after Suventris Syrup and CystEvit Tablets combination therapy when compared to stand ofcare.Timepoint: 120 days	—

Countries

India

Contacts

Public ContactDisha Shetty

Samahitha Research Solutions

sri@samahitha.com6364147989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026