Study the effect of Sundari Jeevak syrup in Kashtartava (Primary dysmenorrhea)

Phase 2

Completed

• Conditions: Primary dysmenorrhea,

• Registration Number: CTRI/2020/01/022673
• Lead Sponsor: Multani Pharmaceuticals Ltd

Brief Summary

It is an open labeled, single armed, single center, prospective, interventional clinical study to evaluate the efficacy of the Sundari Jeevak syrup on 50 patients suffering from *Kashtartava* (Primary dysmenorrhea). The study will be conducted in Panchakarma department, NIA, Jaipur, Rajasthan. It will be advised to subjects to Sundari Jeevak syrup will be given, 14 days after menstruation till the commencement of next cycle for two consecutive cycles. The primary outcome measure will be to assess the efficacy Sundari Jeevak syrup in patients of *Kashtartava* (Dysmenorrhea) by assessing the Changes pain and duration of pain during menstruation. The secondary outcome will be assess the changes in associated symptoms likenausea, *Chhardi, Vibandha, Atisara, Shrama, Aruchi, Shirasula* etc

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Females suffering from primary dysmenorrhea more than 3 consecutive cycles.
• Female presenting primary dysmenorrhea with or without any of the following symptoms associated with- Any kind of pain like headache, backache, abdominal pain, body ache, Nausea and vomiting, Weakness.
• Psychological symptoms- like anxiety, stress, depression, irritability, restlessness.
• 4.Willing to participate in the trial.
• 5.Readiness to sign an informed consent form.

Exclusion Criteria

• Patients having congenital anomalies, patient is suffering from acute infections, cervical stenosis etc.
• Patients with chronic illness, patient using an intrauterine contraceptive device, and patient with menorrhagia or any uterine pathology (fibroid, adenomyosis, endometriosis etc.) will be excluded from the study.
• Lactating female.
• Individuals participating in any other clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes pain (Primary dysmenorrhea).	90 days

Secondary Outcome Measures

Name	Time	Method
Changes in associated symptoms	90 days

Trial Locations

Locations (1)

National institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National institute of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Gopesh Mangal

Principal investigator

8619849011

gmangal108@gmail.com