Clinical Study of polyherbal formulations for pre menstrual syndrome.

Comparative Clinical Assessment of Two Polyherbal Formulations in Menstrual Health – A Proof of Concept - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068685

Enrollment

Registered

2024-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: N943- Premenstrual tension syndrome

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Provision of signed and dated informed consent prior to any study-specific procedures. 2. Healthy females in the age group of 19-45 years with a history of psychological or somatic signs and symptoms of PMS 3. Females with irregularity menstrual cycles (based on history) 4. Not on any hormonal therapy during and one month prior to the trial. 5. Willing to practice birth control methods other than hormonal contraception (barrier/condoms) during study period (as applicable) 6. Willing to follow study related procedures.

Exclusion criteria

Exclusion criteria: 1. Subjects not willing to sign ICD. 2. Menopausal or peri-menopausal based on history 3. Currently pregnant or breastfeeding 4. Planning pregnancy in next 3-4 months 5. Not willing to practice birth control methods other than hormonal contraception (oral contraceptive pill) during the course of the trial. 6. Requirements of any prohibited concomitant medications (Oestrogen/Progesterone/ etc) 7. Gynaecological conditions like genital tuberculosis, history of any malignancy or organic lesions like polyps, fibroids, endometriosis etc. on USG 8. Prescence of chronic systemic conditions like endocrinal disorder like Cushing’s syndrome, hypertension, heart diseases, diabetes, hepatic disease, renal disease, or any psychiatric condition (medical history) 9. Subjects who in Investigators’ opinion will not be able to follow study related procedures.

Design outcomes

Primary

Measure	Time frame
•Re-establishes cyclical bleeding. •Controls excess bleeding occurring in the menstrual cycle. •Relieves from backache, pelvic pain, abdominal cramps. •Controls leucorrhoea Improvement basis change in CGI scale •Modification in Quality of Life (QoL) – includes fatigue, Mood swing, hot flushes on sole, restlessness, anxiety, irritability, bloating, food cravings, nausea, vomiting, diarrhoea/ constipation, headaches /joint pains etc (assessed by psychologist as per Annexure 2) Timepoint: 30, 60, 90 days	—

Measure

Time frame

•Re-establishes cyclical bleeding. •Controls excess bleeding occurring in the menstrual cycle. •Relieves from backache, pelvic pain, abdominal cramps. •Controls leucorrhoea Improvement basis change in CGI scale •Modification in Quality of Life (QoL) – includes fatigue, Mood swing, hot flushes on sole, restlessness, anxiety, irritability, bloating, food cravings, nausea, vomiting, diarrhoea/ constipation, headaches /joint pains etc (assessed by psychologist as per Annexure 2) Timepoint: 30, 60, 90 days

—

Secondary

Measure	Time frame
• Improvement in PCV, and Hb%, glowing skin. • Regularization of Menstrual Irregularities (oligomenorrhea, menorrhagia, Polymenorrhea, hypomenorrhea – DUB) Timepoint: Pre and post treatment	—

Countries

India

Contacts

Public ContactDr Baidyanath Mishra

Shisu Bhawan

drmohanty.og@gmail.com9437164692

Outcome results