A clinical trial to study the effect of Agnimukha Churna in patients with Udavartini Yoni Vyapad (Primary Dysmenorrhea) & compare the efficacy of this drug with Rajahpravartini Vati .

A randomized controlled clinical study to evaluate the effect of Agnimukha Churna in Udavartini yonivyapad (Primary Dysmenorrhea) - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060751

Enrollment

Registered

2023-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: N944- Primary dysmenorrhea

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patient fulfilling any of the following diagnostic criteria will be selected for the study. 1. Pain in the lower abdomen which begins one or two days before menstruation or with the onset of menstruation and lasting for few hours or one to two days. 2. Pain in the lower abdomen and suprapubic region, radiating to medial aspect of the thighs and lower back. 3 .Painful menstruation also associated with symptoms like headache, fatigue, nausea, vomiting and constipation. 4 .Age between 16 to 30 years 5. Married or unmarried females 6.History of painful menstruation for at least 3 consecutive cycles 7.Patients with regular menstrual cycles (21 to 35 days)

Exclusion criteria

Exclusion criteria: 1.Cases of secondary dysmenorrhea with pelvic pathology – Fibroid uterus, endometriosis, Adenomyosis, AUB, PID, Ovarian cyst, cervicitis. 2. Patients with Congenital anomalies of Reproductive tract 3.Patients with systemic diseases like Diabetes Mellitus, Hypertension, Anaemia 4.Patients on Hormonal therapy, contraception and Intra uterine contraceptive device. 5.Endocrinal disorders like thyroid abnormalities and PCOS 6.Surgical and Malignant conditions

Design outcomes

Primary

Measure	Time frame
Pain criteria will be assessed using VAS grading. a)Intensity of pain b)Site of pain c)Pain associated with symptoms such as nausea, vomiting, headache, constipation & fatigue. d)Duration of pain e)Nature of pain Timepoint: 4th day of each menstrual cycle for 3 consecutive cycles.	—

Secondary

Measure	Time frame
a) Intensity of pain: VAS Scale: Mild / Moderate / Severe b) Site of pain: Lower abdomen & suprapubic region Lower back c) Associated symptoms: Headache, fatigue, nausea, vomiting and constipation. d) Duration of pain: Upto 24 hours/ 24 to 48 hours/ 48 to 72 hours. e) Nature of pain: Dull / Colicky / Spasmodic Timepoint: For 1 cycle on the 4th day of menstrual cycle after treatment.	—

Countries

India

Contacts

Public ContactChinmayi M S

Alvas Ayurveda Medical College , Moodbidri

drkavithapradeep@gmail.com9008979169

Outcome results