Comparative Efficacy of Chandanadi Basti along with Pradarantaka Lauha and Pradarantaka Lauha Alone on Hemoglobin level in Patients with Raktapradara (w.s.r Menorrhagia)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome will be the change in hemoglobin level from baseline in patients with Raktapradara (w.s.r Menorrhagia) ( for both the group A and B)
研究概览
简要总结
Raktapradara (Menorrhagia) is a prevalent gynecological issue, categorized as Yoni-garbhashayvikar in Ayurveda. Major symptoms include Artava ati-pravrutti (excessive bleeding greater than 80 ml per cycle), Deergha kala pravrutti (prolonged duration greater than 7 days), Daha (burning sensation), and Adho vankshana pradesha shoola (pain in the lower abdomen). This heavy menstrual bleeding can lead to Anemia (Pandu), which manifests with symptoms such as Durbalya (Weakness), Shrama (Fatigue), Shweta avabhasata (Pallor), Bhrama (Giddiness), Shwasa (Breathlessness), and Annanaabhilasha (Loss of appetite).
These conditions significantly affect a woman’s physical, social, and emotional quality of life.
Acharya Charaka mentioned Chandanadi Basti in Siddhi Sthana and also Bhaishajya Ratnavali in Stri Rogadhikara advocates the use of Pradarantaka Lauha in managing Panduand Raktapradara.
Chandanadi Basti combines Raktasthapaka (hemostatic) action with Vatapitta Shamaka (balancing Vata and Pitta), Garbhashaya Balya (uterine tonics), and Samprapti Vighattan(pathogenesis breakdown), aiming to control or cure both Panduand Raktapradara.
This research focuses mainly on exploring the potential benefits of Chandanadi Basti and Pradarantaka Lauha in managing these interconnected conditions by improving hemoglobin level and effectively managing Menorrhagia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Heavy menstrual flow greater than 80ml/cycle
- •Hemoglobin level 7.0-10.9gm/dl
- •Patient willing to provide written informed consent.
排除标准
- •Patients who are contraindicated for Niruha basti and Anuvasana basti, will not be included in Group A.
- •Pregnant women and lactating mothers.
- •Known cases of aplastic anemia, sickle cell anemia, thalassemia, autoimmune hemolytic anemia, chronic blood loss anemia like gastrointestinal bleeding or any infection or any documented history of blood disorders.
- •Patients with co-morbid conditions such as Hypertension (systolic greater than 150 mm Hg and diastolic greater than 100 mm Hg despite antihypertensive) and Diabetes Mellitus (having HbA1c greater than 7.0% despite anti-diabetic medications).
- •Patients planning to undergo or already had any gynecological surgery.
- •Patients suffering from major illnesses such as malignancy, Ascites, Intestinal perforation, Intestinal obstruction etc.
- •Patients with severe impairment in LFT and KFT.
- •Patients on antiretroviral, anti-tuberculosis, anticoagulants, anticonvulsants, psychotropic medications, cardiovascular agents, or immunosuppressants.
- •Excluding patients who have uterine fibroids that are specifically responsible for causing bleeding per vagina.
- •Causes of bleeding per vagina such as polyps, adenomyosis, (malignancy, and hyperplasia, as ruled out through a per-speculum examination, USG pelvis, or other symptoms).
结局指标
主要结局
The primary outcome will be the change in hemoglobin level from baseline in patients with Raktapradara (w.s.r Menorrhagia) ( for both the group A and B)
时间窗: The primary outcome will be the change in hemoglobin level from baseline in patients with Raktapradara (w.s.r Menorrhagia) ( for both the group A and B) at 30, 60 and 90th days
次要结局
- The secondary outcome will be the change in the grading of clinical features of Raktapradara (w.s.r Menorrhagia) & Assessment of menstrual blood loss from the baseline.(Secondary outcomes will be measured by through grading system of clinical features of Raktapradara (w.s.r Menorrhagia) & Menstrual blood loss will be assessed by using the PBAC (Pictorial Blood Loss Assessment Chart) at 90th day)
研究者
Ayushi Gupta
Ayurvedic and Unani Tibbia College and Hospital