A COMPARATIVE PHARMACO-CLINICAL STUDY OF AGNIMANTHA (PREMNA INTEGRIFOLIA LINN & CLERODENDRUM PHLOMIDIS LINN.) IN PANDU ROGA W.S.R. TO IRON DEFICIENCY ANEMIA.
试验速览
- 阶段
- 2/3 期
- 状态
- Not Applicable
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief in Pandu Roga Subjective parameters
研究概览
简要总结
NEED OF STUDY: - Anemia is a serious worldwide public health problem that particularly affects young children, mensurating women, adolescent girls, pregnant women, and post-partum women. Iron deficiency anemia can cause reduced work capacity in adults, impacting motor and mental development in children and adolescents. There is some evidence that iron deficiency anemia affects cognition in adolescent girls and causes fatigue in adult women. Iron deficiency anemia may affect visual and auditory functioning and is weakly associated with poor cognitive development in children.
WHO estimates that 40% of children 6 months years of age, 37%of pregnant women, and 30%of women 15-49 years of age group worldwide are anemic.
The aim of this study is To evaluate the comparative efficacy of drug Agnimantha’s varieties (Premna integrifolia &Clerodendrum phlomidis) in the management of Pandu roga.
open-labeled clinical study will be carried out by selected patients from OPD of the department of “Kaya Chikitsha at Pt. Khushi Lal Sharma Govt. (Auto.) Ayurveda College and
Institute Bhopal. this study will be done on a total of 60 diagnosed patients of Pandu roga (Anemia especially Iron deficiency anemia) in two drug groups
**(A) Brihat Agnimantha (**Premna integrifolia Linn.) and
**(B) Laghu Agnimantha (**Clerodendrum phlomidis Linn.f.) ghan vati.
selected patients will be investigated by objective parameters - Complete Blood Count (CBC), ESR, And subjective parameters-
1. Panduta (Pallor of the body)
2. Anna-Aruchi (Loss of appetite)
3. Pindikoudvesthan (Cramp in calf region).
4. Akchikutshotha (Periorbitledema)
5. Dourbalya (Weakness)
6. Ayasena Shwasa (exertional dyspnoea)
7. Hriday Spandana (Palpitation)
The outcome of the study will be measured with the help of specially designed proforma and modern parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged between 15 to 55 years without any discrimination of gender, caste, religion, etc.
- •Patients fulfilling the diagnostic criteria.
- •Individuals having clinical Sign and symptoms of Pandu according to Ayurvedic classics.
- •Individuals who will give written consent for the study.
- •Hb% between 8 gm to 11gm.
排除标准
- •Individuals having any known systemic disorders like Cardiac disorders, Renal and Hepatic impairment, Diabetes Mellitus, Thyroid disorders, Gynecological diseases, and any type of Cancers.
- •Pregnancy and Lactating mothers.
- •Others type of known anemia like hemolytic, megaloblastic, pernicious, sickle cell and all types of secondary congenital hereditary and genetically acquired anemia will be excluded.
- •Hb level less than 8 gm/dl.
- •Individuals below 15 years and above 55 years.
- •Any continuing blood loss e.g., Hematemesis, Melena, bleeding piles, etc.
结局指标
主要结局
Relief in Pandu Roga Subjective parameters
时间窗: subjective parameters will be compared after 30-days intervals.
1.Panduta (Pallor of the body)
时间窗: subjective parameters will be compared after 30-days intervals.
2.Anna-Aruchi (Loss of appetite)
时间窗: subjective parameters will be compared after 30-days intervals.
3.Pindikoudvesthan (Cramp in calf region).
时间窗: subjective parameters will be compared after 30-days intervals.
4.Akchikutshotha (Periorbitledema)
时间窗: subjective parameters will be compared after 30-days intervals.
5. Dourbalya (Weakness)
时间窗: subjective parameters will be compared after 30-days intervals.
6. Ayasena Shwasa (exertional dyspnoea)
时间窗: subjective parameters will be compared after 30-days intervals.
7.Hriday Spandana (Palpitation)
时间窗: subjective parameters will be compared after 30-days intervals.
次要结局
- Change in Mean Haemoglobin level and Relief in objective parameters Like CBC, ESR(objective parameters like CBC and ESR will be compared after 30-day intervals.)
研究者
DrTej singh Jatav
Pt.Khusi Lal Sharma Government Autonomous Ayurveda College and Institute