Randomized Clinical Study to compare the efficacy of Vatsak Beejadi Churanam with Punarnava Mandoor in improving Haemoglobin level in Pandu Rog Iron deficiency Anaemia

INTRODUCTION:

Pandu is a rasa pradoshaj vikar, it is due to excessive exacerbations of three doshas especially pitta afflicts dhatus as a result complexion, strength, unctuousness . Pandu is a symptom as well as a disease characterized by pallor discolouration. It mostly resembles with Anaemia of modern science.

Anaemia is a condition in which the number of red blood cells or the Haemoglobin concentration within them is lower than normal. 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. This results in symptoms such as Fatigue, Weakness, Dizziness and Shortness of breath, among others. The most common causes of anaemia include Nutritional deficiencies, particularly Iron deficiency, though deficiencies in Folate, vitamins B12 and A are also important causes; Haemoglobinopathies; and Infectious diseases, such as Malaria, Tuberculosis, HIV and Parasitic infections.Anaemia is associated with Fatigue, Weakness, Dizziness and Drowsiness.

The signs include loss of normal colour in the skin and also in the lips, tongue, nail beds and the blood vessels in the sclera part of the eye. Without treatment, Anaemia can worsen and become underlying causes of chronic ill health, such as impaired foetal development during pregnancy, delayed cognitive development and increased risk of infection in young children and reduced physical capacity in all people.

Low birth weight infants, young children and women of child bearing age are particularly at risk of anaemia.

Lacunae in existing knowledge & Need of Study –

There are several approaches for managing anemia to certain extent . Iron supplementation is most recommended drug in this category. The most common side effects of iron supplementation are nausea/ vomiting , constipation or dairrhea , flatulence , metallic taste, staining of teeth , or epigastric distress. Consider this the search for more ayurvedic drugs to control anemia is an alternative approach these days

 Proposed outcome:

Correction of functional status of digestive system as well as hepatobiliary system so that it leads to better absorption of iron which we take in our daily diet.

RESEARCH QUESTION:

Is there any difference in the efficacy of Vatsakbeejadi Churnam and Punarnava Mandoor in improving low Haemoglobin status in Pandu Rog?

NULL HYPOTHESIS (H0) -There is no difference in effectiveness of VatsakBeejadi Churanam and Punarnava Mandoor for improving Haemoglobin deficiency status in Pandu Roga.

ALTERNATIVE HYPOTHESIS – (H1)   VatsakBeejadi Churanam is more effective than Punarnava Mandoor for improving Haemoglobin deficiency status in Pandu Roga.

(H2) Punarnava Mandoor is more effective than Vatsak Beejadi Churanam for improving Haemoglobin deficiency status in Pandu Roga.

AIM- To compare the efficacy of Vatsakbeejadi Churanam with Punarnava Mandoor for improving Haemoglobin deficiency status in Pandu Roga.

OBJECTIVES –

PRIMARY OBJECTIVE- To compare the effectiveness of Vatsakbeejadi Churanam with poonarnava mandoor in Improving Haemoglobin level of subjects.

SECONDARY OBJECTIVE- To compare the effectiveness of Vatsakbeejadi Churanam with poonarnava mandoor in improving haemoglobin level of subject

in improving following clinical features-

Panduta (Pallor)

Swasa(Dyspnoea)

Hrud - spandanam (Palpitation)

Gatrashool (Bodyache)

Bhrama (Giddiness)

Pindiko-dveshtan (Calf -claudication)

Shram (Fatigue)

 STUDY DESIGN-

Single centred,

Open label,

Parallel arm study with comparator group

Interventional study,

Without any crossover

STUDY SETTING- The subject will be taken from O.P.D. and I.P.D. of Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi.

SAMPLE CLASSIFICATION:

Group A: Punarnava Mandoor

Group B: Vatsakbeejadi Churanam

SAMPLE SIZE– 25 cases each

NO. OF GROUPS- Two groups

Group A (Comparator group) -

25 patients will be randomly selected for this group and they will be treated for 45 days as under.

Punarnava Mandoor 2-tab (250mg each) BD after meal with takra for 30 days.

Group B (Trial group) -

25 patients will be randomly selected for this group and they will be treated for 45 days as under.

5gm Vatsakbeejadi Churanam twice a day after meal with honey for 30 days.

INCLUSION CRITERIA -

Patients between the age group 18 and 60 years, irrespective of gender, caste and religion

Patient not suffering from any severe disease other than Iron deficiency Anaemia.

Haemoglobin level -between 6-10 gm/dl

Patient having score between 7 to 21 of subjective criteria

Patient willing to sign the informed consent for study.

Patient who are able to take medicine orally.

Patient who are not registered in any other research project

EXCLUSION CRITERIA -

Patients suffering from any other systemic diseases .

Age <18 years and more than 60 years

Haemoglobin level-below 6 gm/dl and more than 10 gm/dl

Pregnant women and lactating mothers

Patient not willing to sign the informed consent

Patient who are not able to take medicine orally

Patient registered in any other research projects

Patient already taking any medicine for Anaemia

TOTAL DURATION OF TRIAL: - 45days

DURATION OF DRUG ADMINISTRATION: -30 days

FOLLOW UP- on 45th day

DURATION OF STUDY- 18 months

PRIMARY ASSESMENT CRITERIA:

Improving the Haemoglobin level

SECONDARY ASSESMENT  CRITERIA:

The subjective criteria for  secondary assessment include the

A.     Pandutaa (Pallor),

B.    Swasa (Dyspnoea),

C.    Bhrama (Giddiness)

D.    Pindiko-dveshtan (Calf-claudication*)*

E.    Gatrashool (Bodyache)

F.Hrud-spandanam (Palpitation)

G     Shram (Fatigue)

EXPECTED OUTCOME OF THE STUDY

Improvement in the subjective parameters of Pandu roga ( Iron deficiency aneamia)

 Improvement in the objective parameters of Pandu roga( Iron deficiency aneamia)