A Comparative clinical study to evaluate the effect of Bhumyamalaki churna and Amlakibeeja churna in Shwetapradara w.s.r. to Bacterial Vaginosis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of trial drug on Shwetapradara (Bacterial Vaginosis) assessed by the assessment parameters
研究概览
简要总结
Study Title: A Comparative Clinical Study to Evaluate the Effect of Bhumyamalaki Churna and Amlakibeej Churna in Shwetapradara with Special Reference to Bacterial Vaginosis
Clinical Trial Registration Number: (To be assigned)
Principal Investigator: Dr. Pradnya Hanumant Raut, 2 nd Year PG Scholar, Department of Prasuti Tantra and Stree Roga, SDM Trust’s Ayurvedic Medical College, Terdal.
Study Objectives:
- To evaluate the efficacy of Bhumyamalaki churna in the treatment of Shwetapradara (Bacterial Vaginosis).
- To evaluate the efficacy of Amlakibeej churna in the treatment of Shwetapradara.
- To compare the efficacy of Bhumyamalaki churna and Amlakibeej churna in Shwetapradara.
Study Design: A randomized controlled clinical trial.
Sample Size: 40 female participants, divided into two groups:
- Group A (20 patients): Treated with Bhumyamalaki churna (6g twice a day for 30 days).
- Group B (20 patients): Treated with Amlakibeej churna (6g twice a day for 30 days).
Intervention:
- Group A: Bhumyamalaki churna with tandulodak as an anupana (before food).
- Group B: Amlakibeej churna with tandulodak as an anupana (before food).
Inclusion Criteria:
- Women aged 18–40 years presenting with the characteristic symptoms of Shwetapradara (Bacterial Vaginosis), including abnormal vaginal discharge, itching, foul smell, and associated discomfort.
Exclusion Criteria:
- Patients with systemic disorders, congenital reproductive organ abnormalities, sexually transmitted diseases, or malignancies.
- Pregnant or lactating women, women with uterine or cervical fibroids, or those on oral contraceptives.
Outcome Measures:
- Subjective parameters such as vaginal discharge, odor, itching, burning sensation, and pain.
- Objective assessments include the amount and type of discharge, pH level, and Whiff test.
Trial Duration: 45 days (with assessments on day 15, day 30, and final follow-up on day 45).
Ethical Approval: The study has received approval from the institutional ethics committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with Pratyatma Lakshana’s of Shwetapradara (Bacterial vaginosis) – Yonigata Shwetasrav, Yonikandu, Daurgandhya, Yonidaha and Katishoola.
- •â€¢ Patients between age group 18 years to 40 years.
- •â€¢ Irrespective of marital status.
排除标准
- •Patients with Systemic disorder like DM.
- •â€¢ K/C/O Reproductive Organs Congenital abnormalities.
- •â€¢ K/C/O STD, PID, Women having Benign and Malignant tumors.
- •â€¢ Pregnant and lactating women, OCP using women.
- •â€¢ Women already diagnosed with Cervical fibroid, Uterine Fibroid.
结局指标
主要结局
Effect of trial drug on Shwetapradara (Bacterial Vaginosis) assessed by the assessment parameters
时间窗: 15th day, 30th day, 45th day
次要结局
- Improvement in associated symptoms of Shwetapradara (Foul smell, Vaginal Itching, burning sensation at vagina, lowback ache):(Graded improvement based on patient-reported outcomes.)
研究者
DR PRADNYA HANUMANT RAUT
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE PADMA AYURVEDA HOSPITAL AND RESEARCH CENTRE TERDAL