A Phytopharmacotherapeutic evaluation of Ambasthaki Hibiscus Sabdariffa Linn Sp.Pl. calyx in the management of Pandu Roga Iron Deficiency Anaemia
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Improvement in the symptoms of Pandu Roga (Iron Deficiency Anaemia). Increase in the HB % level. Increase in the level of range of Iron profile
Overview
Brief Summary
Anaemia is defined as haemoglobin (Hb) levels <12.0 g/dL in women and <13.0 g/dL in men. Haemoglobin is needed to carry oxygen and if you have too few or abnormal red blood cells, or not enough haemoglobin, there will be a decreased capacity of the blood to carry oxygen to the body’s tissues. Various reasons of anaemia are deficiencies in foliate, vitamins A, B12, haemoglobinopathies; and infectious diseases, but major reason of anaemia is iron deficiency. Iron is abundant in HB that carries oxygenated blood to various parts of the body. Iron Deficiency Anaemia occurs when iron losses or physiological requirements exceed absorption. Blood loss in females through the menses, or blood loss from GI tract, genitourinary tract, malabsorption, pregnancy, exceed use of NSAID etc. are the main causes for iron deficiency anaemia. In Ayurveda anaemia can be well correlated with Pandu roga. Pandu is pitta pradhana vyadhi associated with rasa and rakta dhatu. In short pandu roga means raktalpata. Pandu is a clinical condition characterized by whitish yellow discoloration of skin, eyes, nails, weakness, loss of appetite, skin dryness, dyspnoea etc. Hibiscus sabdariffa L., a member of the Malvaceae family, is an annual herb having amla pradhana madhur, tikta, kashaya rasa, Amla vipaka, Dipana property. Chemical composition of Ambashthaki calyx shows that it contains iron and vitamin c which are useful in the management of the Iron Deficiency Anaemia as iron will replace deficient iron on the body and vitamin c helps in the absorption of iron, so taking these points into consideration present study is being planned to evaluate effect of Ambasthaki calyx in the management of Iron Deficiency Anaemia. Total no of patients is 66. Ambasthaki calyx churna will be given 5gm twice a day with luke warm water after meal. Study design is single arm, single centred, interventional type, clinical study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with symptoms of Pandu Roga.
- •Patients with Hb% within level of 7-11 gm /dl.
- •Patients of either sex with age group of 20-50 years.
Exclusion Criteria
- •Pandu Roga in age group below 20 years and above 50 years.
- •Haemoglobin level less than 7gm/dl.
- •Anaemia due to internal bleeding, external bleeding, gastric and duodenal ulcer, haemorrhoids, pregnancy induced Anaemia.
- •Patients suffering from other systematic diseases like AIDS, Cancer, Tuberculosis, Diabetes Mellitus etc.
- •Patient with history of disorders related with haemopoietic system like Sickle Cell Anaemia, Haemophilia.
- •Patients suffering from other infectious diseases like Malaria, Jaundice etc.
- •Pregnant woman and Lactating mothers.
- •Other causes of Anaemia apart from iron deficiency, apparent by history, physical examination, laboratory tests.
- •Patients with hepatic and renal dysfunction.
Outcomes
Primary Outcomes
Improvement in the symptoms of Pandu Roga (Iron Deficiency Anaemia). Increase in the HB % level. Increase in the level of range of Iron profile
Time Frame: 60 days
Secondary Outcomes
- The study will provide easily available, cost effective, safe treatment modality with lesser side effects.(60 days)
Investigators
Gitanjali Ambad
Choudhary Brahm Prakash Ayurveda Charak sansthan Khera Dabar New Delhi South west DELHI