Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

Acharya Vagbhat described the importance of Stanya for child. Stanya kshaya is one of the vikruti of stanya. In stanya kshaya there is kshaya due to dhatu kshaya and dushti. Stanyaksaya is a vital problem with increasing prevalence, ranging from 23-63% in western countries and 30-40% in some part of India.5 As far as Modern medicine concern there is no satisfactory drug for Stanya after the delivery of a child. And mother feeding is utmost essential

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for infant’s initial immunity as well as growth. that’s why in this study Vidarikanda churna with Godugdha is undertaken to evaluate its efficacy in stanyakshaya.

Does Vidarikanda churna with Godugdha effective in the management of Stanyakshaya?

Null Hypothesis: There is no any difference in effectiveness of Vidarikanda churna with Godugdha in the management of Stanyakshay?

Alternative Hypothesis: There is significant difference in effectiveness of Vidarikanda churna with Godugdha in the management of Stanyakshay?

Aim: Study to evaluate effectiveness of Vidarikanda churna with Godugdha in the management of Stanyakshaya.

Primary:

1. To determine the clinical effectiveness of Vidarikanda churna with Godugdha in the management of Stanyakshaya.

Secondary :

1. To study the details of Stanyakshaya according to Ayurveda and modern science.

Study population and sampling: Patients attending OPD/IPD of Prasutitantra and suffering from Stanyakshaya.

Study Site: OPD/IPD of Dept. of Prasutitantra of Ayurveda College & Hospital.

Sample size : Total 46 patients in study Group.

a. Inclusion criteria

1. Mothers suffering from Stanyakshya symptoms like Stanyamlanata and Stanyasambhavalpata having age group between 18 - 40 years.

2. Mother having baby up to 12 months will be selected for study.

3. Patients who are willing to give consent for this study.

b. Exclusion criteria

1. Known case of breast abscess, Mastitis, cysts and tumours of breast, cracked nipples and breast cancer.

2. Patients suffering from Stanyakshaya due to any secondary cause like HIV, TB.

c. Withdrawal criteria

1. Occurrence of serious adverse effects.

2. The protocol has been violated or patient has become uncooperative.

3. The patient is not willing to continue the trial or to follow the assessment schedule.

4. Evidence of any other illness which may interrupt the efficacy of the drug.

Investigations: (if necessary )

1. CBC,

2. Urine Routine

3. Blood Sugar Routine

4. VDRL

5. TSH

6. HIV

7. HbSAg

8. Sickling Test

9. USG

10. Blood Creatinine

Drug and Treatment details :

Grouping:

Drug Review :

Vidarikanda:

पवदलरी मधुरल पस्नग्धल बृंहणी स्तन्यशुक्रदल |

शीतल स्वयला मूत्र्ल च जीवनी ब्वणादल |

गुरुाः पपत्तलस्रपवनदलहलन् हपन्त रसलयनी ||१५५||

भलवप्रकलश-पूवाखण्ड-प्रथमभलग-पमश्रप्रकरण, गुडूछयलपदवगा

पवदलरीकन्द रसं पपबेत स्तण्यक्षय वृद्धये |

तस्चुणा तस्य वृद्धयथा पपबेद्वल क्षीर संयुतम ||

भलवप्रकलश-पूवाखण्ड -बल् प्रकरण, ४/१५

Drug :-Vidarikandha

Latin name:- Pueraria tuberose Dc.

Part use :- kandha

Drug collection/ authentication:

Collection, authentication and standardization of drug:

Ingredients of Vidari will be taken as given quantity., it will be cleaned properly. Then ingredient individually will be crush into mixture and will be prepared fine powder and passed through it sieve number 85. It will be mixed thoroughly to obtain a homogeneous blend. Then it will be packed it in tightly closed containers to protect from light and moisture.

Groups

Study Group

No. of Subject: 46

Drug :Vidari kanda

Dose : 5 gm churna with 100 ml milk twice a daily

Duration: Two weeks

Route of administration: Oral

Follow up: 1st week , 2nd week

Methods of Data Collection relevant to objective

a. Clinical Examination : A detailed Case Record Form including all the classical signs and symptoms of Stanyakshaya will be prepared. Dushti Lakshanas of Dosha, Dushya, Dhatu, Agni and Prakriti etc. will be also included in case report proforma by clinical examination.

b. Literary source: A detailed review of the available literature on the drug and disease, such as classical text of Ayurveda, Nighantus, Modern Pharmacology textbooks. Data will be collected from various books on the field of herbal medicines, periodicals and papers published in the e-journal etc.

c. The patients: A detailed Case Record Form will be prepared. CRF including all the classical signs and symptoms of Stanyakshaya and data for Dushti Lakshanas of Dosha, Dushya, Dhatu, Agni and Prakriti will be taken etc.

Data analysis methods :

Data will be coded in MS excel worksheet. Data will be analyzed in statistical software, STAT, Version 10.1, 2011.

Frequency and percentages will be used to summarize categorical variables like gender, marital status, occupation, education, aahar, vihar, different complaints of participants etc. percentage of relief will be calculated based on subjective & objective criteria. Subjective symptoms will be statistically analyzed by applying suitable test like ‘Wilcoxon Signed Rank test’ within group to compare the results before and after treatment results. Chi square test will be applied for variable to see the association. Level of significance will be taken at 5%.