Clinical Study to Evaluate Safety and Efficacy of a Unani Formulation in Anaemia
- Conditions
- Nutritional anemia, unspecified,
- Registration Number
- CTRI/2023/10/059046
- Lead Sponsor
- National Research Institute of Unani Medicine for Skin Disorders.
- Brief Summary
According to WHO Anaemia is a condition in which the number of red cells or the haemoglobin concentration within them is lower than normal. It is recommended that anaemia should be considered to exist in adult whose haemoglobin levels are lower than 13gm/dl (men) or 12gm/dl (women).Around 30% of the world’s population is anaemic and half of these are believed to have Iron Deficiency Anaemia. Globally, it is estimated that 40% of all children aged 6–59 months, 37% of pregnant women and 30% of women 15–49 years of age are affected by anaemia. The conventional medicine has various side effects such as epigastric pain ,heartburn ,nausea ,vomiting, bloating staining of the teeth, metallic taste, colic, usually constipation and some times diarrhoea. So we select a classical Unani formulation to evaluate the safety and efficacy of the formulation.
This Randomized, Active Controlled, Parallel Group, Open Label, Clinical Study is planned to evaluate the safety and efficacy of the herbomineral Unani formulation *Itrifal Fauladi* in the management of *Faqr al-Dam* .Participants fulfilling Inclusion and Exclusion criteria will receive either Test or Control drug as per Randomization. In Test drug participants will start with *Itrifal Fauladi* 7gm daily for 12 weeks. In Control drug participants will start with Ferrous Sulphate 200 mg/ day once for 12 weeks. Baseline and last follow up laboratory investigation will be done. Duration of study is 84 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- The following participants will be included in the study: 1 Participants in the age group of 18-60 years of either gender having any of the following signs and symptoms.
- Pallor Weakness and Fatigue Dyspnea Palpitation Anorexia Angular Stomatitis and Glossitis Oedema Koilonychia (Spoon Shaped Nail) Dizziness Fainting 2 Heamoglobin: Male, >8.0 gm% & <13gm% Female, >7.0 gm% & < 12.0gm%.
- The following patients will be excluded from the study: 1 Participants aged <18years and >60years of age.
- 2 Participants with haemoglobin < 8.0 & >13 gm% in Males where as <7.0 & >12.0 gm% in Female.
- 3 History of acute blood loss, chronic diseases requiring long term treatment.
- 4 Pregnant and lactating women were excluded.
- 5 Known case of significant Pulmonary/ Cardiovascular/ Hepatorenal Dysfunction/ Malignancy/ HIV Infection /AIDS etc .
- 6 Known allergy to herbal drugs.
- 7 Those who are unwilling to come for regular follow up for the entire duration of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Hb(gm/dl) at 12 weeks from base line 84 days
- Secondary Outcome Measures
Name Time Method 1) Improvement in signs & symptoms 2) Change in Reticulocyte Count, S.Ferritin level, RBC Count, PCV, MCV,
Trial Locations
- Locations (1)
National Research Institute of Unani Medicine for Skin Disorders.
🇮🇳Hyderabad, TELANGANA, India
National Research Institute of Unani Medicine for Skin Disorders.🇮🇳Hyderabad, TELANGANA, IndiaDr Kahkashan BanoPrincipal investigator8318869511bano.kahkashan92@gmail.com