Change in the weight from baseline till the end of the Seeding

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Change in the weight from baseline till the end of the Seeding Program / User Trial treatment

Change in weight for age from baseline till the end of the Seeding Program / User Trial treatment

Change in height for age from baseline till the end of the Seeding Program / User Trial treatment

Change in weight for height from baseline till the end of the Seeding Program / User Trial

 treatment

Change in the height from baseline till the end of the Seeding Program / User Trial treatment

Improvement in physical performance

Improvement in cognitive performance

Change in Minerals level from baseline till the end of the Seeding Program / User Trial treatment

1.

Serum Chlorides

2.

Serum Calcium

3.

Serum Phosphorous

4.

Iron

5.

Zinc

6.

Selenium

7.

Magnesium

8.

Transferrin

9.

Serum Sodium

10.

Serum Potassium

Changes from baseline till the end of the Seeding Program / User Trial treatment in the following blood parameters:

1.

Haemogram

2.

Total Leucocytes

3.

Erythrocyte Count

4.

Haemoglobin

5.

PCV (Packed Cell Volume)

6.

MCV (Mean Corpuscular Volume)

7.

MCH (Mean Corpuscular Haemoglobin)

8.

MCHC (Mean Corpuscular HB Conc.)

9.

RDW (Red Cell Distribution Width)

10.

Platelet count

11.

MPV (Mean Platelet Volume)

12.

Neutrophils

13.

Eosinophils

14.

Lymphocytes

15.

Monocytes

16.

Basophils

17.

Atypical Lymphocyte (ALY %)

18.

LIC (Large Immature Cells)

19.

Premature Leucocytes

20.

PDW (Platelet Distribution Width)

21.

ESR-Erythrocyte Sedimentation Rate, 1st hour

22.

Clotting Time

23.

Reticulocyte count

Lipid Profile

1.

Serum Total Cholesterol

2.

Serum Triglycerides

3.

Serum HDL Cholesterol

4.

Serum LDL Cholesterol

5.

VLDL

6.

LDL/HDL Ratio

7.

CHOL/HDL Ratio

Liver Function Tests

1.

Serum SGOT (AST)

2.

Serum SGPT (ALT)

3.

Serum Gamma GT (GGTP)

4.

Serum Total Protein

5.

Serum Albumin

6.

Serum Globulin

7.

A/G Ratio

8.

Serum Total Bilirubin

9.

Direct Serum Bilirubin

10.

Indirect Serum Bilirubin

11.

Alkaline Phosphatase

12.

Plasma Glucose

Renal Function Tests

1.

Serum Urea

2.

Blood Urea Nitrogen

3.

Serum Creatinine

4.

Serum Uric Acid

Assay for Immunological Parameters

1.

IgG (Total)

2.

IgM (Total)

3.

IgA (Total)

4.

CD4-CD8 count

Change from baseline till the end of the Seeding Program / User Trial treatment in the urinalysis parameters of –

Urine Routine & Microscopy

1.

Colour

2.

Transparency

3.

Reaction (pH)

4.

Specific gravity

5.

Albumin

6.

Sugar

7.

Urine Acetone

8.

Blood

9.

Bile pigments

10.

Bile salts

11.

Urobilinogen

12.

Red blood cells

13.

Pus cells (Leucocytes)

14.

Epithelial cells

15.

Crystals

16.

Cast

17.

Bacteria

Treatment-emergent serious adverse events

Treatment discontinuation due to adverse events

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