Clinical study of khajura on hemoglobin percentage with special reference to sushrutas rakta dhatu poshankal

PURPOSE OF THE STUDY

“To Assess Effect Of Khajura With Dhatriloha And Dhatriloha Alone On Haemoglobin Percentage With Special Reference To Sushrutas Rakta Dhatu Poshankal.â€

 AIMTo Compare The Effect Of Khajur With Dhatriloha And Dhatriloha Alone On Haemoglobin Percentage With Special Reference To Sushrutas Rakta Dhatu Poshankal.â€

 OBJECTIVESØ  Primary objectives: - : To compare the effect of Khajura with dhatriloha and dhatriloha alone on Haemoglobin Percentage With Special Reference To Sushrutas Rakta Dhatu Poshankal.

Ø  Secondary objectives**:-** To study the impact of khajura as nutritional Supplementation on sushrutas rakta dhatu poshankal.

Tools for Primary Objectives:

1.      To assess the effect of Khajura with dhatriloha on Haemoglobin Percentage With Special Reference To Sushrutas Rakta Dhatu Poshankal.

2.      To assess Probable mode of action of Khajura with dhatriloha and dhatriloha alone on Haemoglobin Percentage With Special Reference To Sushrutas Rakta Dhatu Poshankal.

3.      To study the classical and recent literature regarding khajura, Collection and  authentication of sample khajura.

4.      Preparation of          khajura laddu.

5.      To Revalidate the Rakta dhatu shaya lakshanas “Raktemlashishirapriti†in rakta dhatu shaya.

6.      Haemoglobin percentage was estimated by using sahli‟s haemoglobinometer or  lab test.

7.        Complete Blood Count (CBC)

8.      To study the impact of khajura as Nutritional supplementation on Haemoglobin  level.

9.      To study the impact of khajura as Nutritional supplementation on Sushrutas Rakta Dhatu Poshan kala.

10. To study whether individual having Rakta kshaya has craving for Amlasheet Dravya.

MATERIALS AND METHODMATERIALS –

1.      Khajura laddu – Self Prepared by Investigator.

2.      Haemoglobin percentage - Sahli‟s Hemoglobinometer.

3.      Complete Blood Count (CBC Count)

METHODOLOGY1)         Type of Study Design – Open Randomized Controlled clinical study

2)       Randomization procedure - Samples will be collected by Random sampling and labelled them

3)         Place of study – Researcher concern places.

4)         Duration of Study (Setting) - 3 Yrs.

5)       Statistical analysis – Inference will be drawn by applying this test – Paired„t‟ test.

6)       Sample size – 310 Patient15

 PLAN FOR THE STUDYØ  The patients in the study will be selected randomly from respective study    centre in same season.

Ø  310 patient15 divided in 2 groups will be taken on the basis of inclusion and exclusion criteria i.e. assessment criteria.

Ø  Each patient will be thoroughly examined according to CRF.

Ø  Hb% and CBC count will be measured by lab test before and after 30days

Ø  Two group will be done, one group will be administered khajura with dhatriloha and another group will be administered only dhatriloha.

Ø  On every 5th day only haemoglobin percentage will be measured.

Ø  A haemoglobin level of male less than 13g/dl and female less than 12 g/dl has been defined as border line anaemia so Border line anaemic patient will be selected.

Ø  Khajura laddu in 10 gram will be administered at Rasayan kala (In early morning on empty stomach) every day total 30 day.

Ø  Duration of administration of Khajura laddu is 30 days.

Ø  The patient will be assessed on the basis of Haemoglobin percentage and grading scales are adopted to assess the grading system of rakta dhatu shaya lakshana.

 â€¢         Duration of treatment – 1month

All the selected patients fulfilling the criteria of selection will be randomly Divided into two groups –

 I.            Group A : This group will be termed as Experimental / Trial group.

 a)  No. of patients              : About 155 patients

b)  Treatment : This group will be administered Khajura laddu                            with dhatriloha26

c)       Praman

1.      Khajura laddu in 10 gram of khajura laddu will be administered at Rasayan kala (in early morning on empty stomach) every day.

 (Manufactured by company                   - Khajura marketed by                Lion

Company ISO certified- Highly accepted, rated and tested product. FSSAI certified)

 2.      Dhatriloha - 1 tab of 250 milligram

Manufactured by company - Baidyanath Company

 d)   Duration – 30 day

 ii)         Group B: This group will be termed as control group.

  a)     No of patients            : About 155 patients.

  b)   Treatment                     : This group will be administrating with only

 dhatriloha.

 c)  Praman                        : Dhatriloha – 1 tab of 250 milligram.

  d)   Duration – 30 day

 (Dhatriloha – Ref- Bhaishajya Ratnavali Pandurogadhikar)

Treatment Schedule for 2 Groups

Screening and selection of the patients will be carried out as per inclusion and exclusion criteria.

Screening for selection criteria

Included for Study with Investigation Day 0

Randomization - Samples will be collected by Random    sampling and labelled them.

Group A Experimental Group

 Group B control group

Follow up every day

for administration of khajura laddu.

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On every 5th day only haemoglobin percentage will be measured also Investigation on 5th day and 30th day by lab test - hb% and CBC will be done

  Statistical analysis with Appropriate test

Interpretation of Result

 S.O.P Of Khajura Laddu :-

1)     Preparation – Self Prepared by Investigator.

2)     Procedure –

a)     Manually removal of seed from khajura.

b)     Grinding of khajura in mixer grinder.

c)      Obtaining khajura paste and then lastly prepared khajura laddu

3)     Diet – Routine diet.