An Open labelled, Active Controlled, Randomized, Clinical Trial to Evaluate the Effect of Saptavarti Mahakalyanaka Ghrita in the management of Pandu with special reference to Megaloblastic Anemia.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is an open-labelled, randomized, active-controlled clinical trial designed to evaluate the efficacy of Saptaavarti Mahakalyanaka Ghrita in the management of Pandu Roga with special reference to Megaloblastic Anemia (Vitamin B12 deficiency anemia). Megaloblastic anemia results from impaired DNA synthesis due to Vitamin B12 deficiency, leading to macrocytic anemia and possible neurological complications, and it is correlated in Ayurveda with Pandu Roga characterized by pallor, weakness, and fatigue. A total of 60 patients aged 18–60 years with confirmed B12 deficiency (Serum B12 <200 pg/mL, MCV >100 fL, low Hb) will be randomly divided into two groups: the trial group receiving Saptaavarti Mahakalyanaka Ghrita and the control group receiving Methylcobalamin 500 mcg for 90 days. Assessment will be based on subjective parameters (Pandu symptoms and Fatigue Assessment Scale) and objective parameters (Serum B12 and CBC including MCV). The study follows AYUSH GCP guidelines, with ethical clearance and CTRI registration, aiming to scientifically evaluate and compare the effectiveness of this classical Ayurvedic formulation with standard Vitamin B12 therapy in managing megaloblastic anemia.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to the age group of 18 to 60 years of either gender irrespective of religion and socioeconomic status Patients already diagnosed with Pandu as well as newly diagnosed cases of Pandu Patients having serum vitamin B12 value less than 200 pg per mL Patients having hemoglobin levels below normal values that is less than 13 percent in men and less than 12 percent in women according to WHO criteria for nutritional anemia Patients having mean corpuscular volume value more than 100 femtoliter.
排除标准
- •Patients with a history of congenital disorders related to the haemopoietic system like SCA, leukaemia & haemophilia.
- •Patients with a history of other systemic diseases, like uncontrolled diabetes mellitus.
- •Patients suffering from disorders of the GIT system associated with gastrointestinal bleeding, like colorectal malignancy, peptic ulceration.
- •Pregnant and lactating women.
- •Immunocompromised Patients-HIV.
- •Patients who are currently participating in any other clinical trials (in the last 2 months).
研究者
Dr Priyanka Vaishnav
Parul institute of ayurved