A Clinical Study Comparing Two Ayurvedic Oral Drugs When Used With Vaginal Wash Locally In Management of Upper Reproductive Tract Infections
- Conditions
- Female pelvic inflammatory disease, unspecified. Ayurveda Condition: PARIPLUTA,
- Registration Number
- CTRI/2025/05/087521
- Lead Sponsor
- Madan Mohan Malviya Govt. Ayurveda college Udaipur, Rajasthan 313001, India
- Brief Summary
This clinical study aims to evaluate and compare the efficacy of Guduchyadi Ghrita and Go-Ghrita, both administered orally along with Panchvalkala Kwatha yoni prakshalana, in the management of Paripluta Yonivyapad, a condition correlated with Pelvic Inflammatory Disease (PID). The primary objective is to assess changes in key symptoms such as pelvic pain, dyspareunia, abnormal vaginal discharge, fever, and dysuria between the two treatment groups. Secondary objectives include a detailed study of the disease’s Ayurvedic and modern pathogenesis and the identification of any adverse drug reactions.
The study is a randomized, open-label, comparative clinical trial conducted over 30 days on 60 married women aged 21 to 50 years, diagnosed with PID. Participants are divided equally into two groups. Group A receives Guduchyadi Ghrita orally (5 ml with milk twice daily) along with Panchvalkala Kwatha for yoni prakshalana (10 gm per vagina for 7 days post-menstruation), while Group B receives Go-Ghrita with the same external procedure. Patients are recruited from the OPD and IPD of Madan Mohan Malviya Government Ayurved College, Udaipur, and written consent is obtained prior to participation.
Inclusion criteria include sexually active women with symptoms like lower abdominal pain, abnormal discharge, backache, dyspareunia, and menstrual irregularities, while exclusion criteria rule out pregnant women and those with severe systemic or gynecological conditions requiring surgery or with malignancies. Randomization is done using a computer-generated sequence and allocation is concealed using SNOSE method.
Assessment is based on subjective symptom scoring and objective findings including laboratory investigations such as CBC, ESR, RBS, LFT, RFT, urine analysis, Pap smear, and pelvic USG, both before and after treatment. Follow-up is conducted every 15 days to monitor progress and compliance. The trial aims to determine the safety and efficacy of these Ayurvedic interventions in managing PID through both traditional and modern diagnostic parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 60
- Married females.
- Patients aged between 21 years to 50 years who are sexually or reproductively active.
- Diagnosed cases of PID.
- Patients suffering from lower abdominal pain, abnormal vaginal discharge, low backache, painful coitus, menstrual disorders etc.
- Patients willing to go through trial.
- Pregnant females.
- Patients with peritonitis.
- Patients with Tubercular tubo-ovarian mass.
- Patients with Appendicitis.
- Patients with Septic abortion.
- Patients who require surgical interventions in cases like pelvic abscess.
- Patients with reproductive malignancies.
- Patients with Ovarian tumour & Ovarian cysts.
- Patient having Pelvic endometriosis.
- Other systemic illness like Uncontrolled DM, Active T.B., Uncontrolled hypertension, Known cases of TORCH infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the symptoms of paripluta yonivyapad w.r.s pelvic inflammatory disease like pelvic pain, dyspareunia, abnormal vaginal discharge, fever, dysuria etc. 30 days
- Secondary Outcome Measures
Name Time Method Changes in all other investigatory parameters (USG-Pelvic region, ESR etc) 30 days
Trial Locations
- Locations (1)
Madan Mohan Malviya Govt. Ayurveda College, Udaipur
🇮🇳Udaipur, RAJASTHAN, India
Madan Mohan Malviya Govt. Ayurveda College, Udaipur🇮🇳Udaipur, RAJASTHAN, IndiaDr Cheshta GautamPrincipal investigator7976511374cheshtagautam52@gmail.com