A clinical trial to study of Brihtyadi Ghan vati and laghu panchmoola kwath prakshalan and taila pichu in paripluta yonivyapad wsr PID

Phase 1/2

Recruiting

• Conditions: Female pelvic inflammatory disease, unspecified. Ayurveda Condition: Paripluta Yonivyapad,

• Registration Number: CTRI/2023/08/056761
• Lead Sponsor: State Ayurvedic college and hospital Lucknow UP

Brief Summary

The study is entitled as" A comparative clinical study to evaluate the effect of brihtyadi Ghan vati with laghu panchmoola kwath prakshalan and taila pichu in paripluta yonivyapad w.s.r PID

Objective of study- To compare the effect of brihtyadi Ghan vati with laghu panchmoola kwath prakshalan and Brihtyadi Ghan vati with laghu panchmoola kwath prakshalan along with laghu panchmoola taila pichu in management of paripluta yonivyapad w.s.r PID



Type of study-Randomised comparative parallel open clinical trial

Administration of trail therapy- Minimum 40 patients having cardinal symptoms of paripluta yonivyapad

Group allocation- Registered patients will be randomly divided into two groups



Group A-Brihtyadi Ghan vati 2 BD (500mg) with water for 21 day and laghu panchmoola kwath prakshalan for 7 day (after clearness of menses)



Group B- Brihtyadi Ghan vati 2 BD ( 500mg) with water and laghu panchmoola kwath prakshalan along with laghu panchmoola taila pichu for 7 day (after clearness of menses)



Duration of trail- 3 consecutive cycle

Follow up during treatment- 3 follow up will be done at every 1month during the therapy

Follow up after the treatment- fourth follow up will be done after 1month of the completion of the trail ( without medicine)



Criteria for the selection patients

Diagnostic criteria-

1.Lower abdomen pain

2.Low back pain

3.Abnormal vaginal discharge

4.Dyspareunia

5.Cervical motion tenderness or adnexal/Fornix tenderness

6.USG report having suggestive finding PID

When 3 and more criteria is fulfilled that it’s said to patients of PID

Assessment criteria-



Subjective criteria-

•Sparshakshama (Tenderness)

•Vedna in shroni vankshan ( pain in lower abdomen)

•Prishtvedna (low back pain

•Yoni srava( vaginal discharge)

•Gramyadharmaruja ( Dyspareunia)



Objective criteria

•Cervical motion tenderness

•Adnexal/ Fornix tenderness

•USG finding ( fluid in pouch of Douglas)



Investigation-

•CBC

•ESR

•RBS

•LFT

•KFT

•Urine examination R/M

•USG pelvis (lower abdomen)/TVS

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 1• Patient willing for trial.
• 2• Married women 3• lower abdomen pain 4• Low back pain.
• 5• Abnormal cervical or vaginal discharge 6• Dyspareunia.

Exclusion Criteria

• 1• Pregnant women 2• Unmarried 3• PID associated with prolapsed uterus.
• 4• Endometriosis/ Chocolate cyst.
• 5• Severe or chronic ill health condition like diabetes mellitus & Hypertension tuberculosis etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2)To assess the efficacy of trial therapy on	Final assessment will be done after completion | of trial of 4 consecutive months (3 months with | clinical therapy and 1 month drug free)
subjective parameters like pain in lower abdomen low back pain vaginal discharge dyspareunia objective criteria like cervical motion tenderness fornix tenderness	Final assessment will be done after completion | of trial of 4 consecutive months (3 months with | clinical therapy and 1 month drug free)
1)To assess the efficacy of Brihatyadi Ghan vati and Laghu Panchmula kwath prakshalan	Final assessment will be done after completion | of trial of 4 consecutive months (3 months with | clinical therapy and 1 month drug free)
with taila pichu in management of Paripluta Yonivyapad	Final assessment will be done after completion | of trial of 4 consecutive months (3 months with | clinical therapy and 1 month drug free)

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of trial therapy on	subjective parameters like pain in lower abdomen low back pain vaginal discharge dyspareunia objective criteria like cervical motion tenderness fornix tenderness USG finding ( fluid in pouch of Douglas)

Trial Locations

Locations (1)

State Ayurvedic college and hospital Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic college and hospital Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

DrRuby Gupta

Principal investigator

7691919450

rubyg3142@gmail.com