Clinical Evaluation of Sahasraveeryadi Granules on General and Reproductive Health of Females
Received: 24-Jun-2022 / Manuscript No. jham-22-69295 / Editor assigned: 27-Jun-2022 / PreQC No. jham-22-69295 (PQ) / Reviewed: 13-Jul-2022 / QC No. jham-22-69295 / Revised: 18-Jul-2022 / Manuscript No. jham-22-69295 (R) / Accepted Date: 18-Jul-2022 / Published Date: 25-Jul-2022 DOI: 10.4172/2573-4555.1000332
Abstract
Within the framework of WHO definition of health as a state of complete physical, mental and social well-being & not merely the absence of disease or infirmity. Reproductive health addresses reproductive processes, functions and system at all stages of life. The reproductive axis is closely linked to nutritional status especially under nutrition in females.Women life is associated with drastic physiological, anatomical & psychological changes during menarche,reproductive period, menopause and post menopause. Deficient food intake, inadequate alimentary regimens, strong dietary restrictions and a general lack of nutrients result in loss of both body weight and physical performance as well as delayed puberty, lengthening of postpartum interval to conception, lower gonadotropin secretion level with alteration of physiological ovarian cyclicity, increase infertility and can worsen the effect of menopausal syndrome.Sahasraveeryadi Granules work as general nutritive tonic for females. The entire reproductive period of females when divided into two gives a first half with better reproductive potential and a second half where reproductive system functions to help women in leading a healthy personal and family life by providing proper hormonal support. The HPO axis is base of normal reproductive function.
Objectives: To evaluate the efficacy of Sahasraveeryadi Granules in improving the general and reproductive health of females and providing a conventional health drink for females.
Conclusion: drug gives optimistic results on these patients. The BMI of all patients increase with moderate to complete relief in all gynaecological symptoms caused because of nutritional deficiency. During study it was observed that there were no side effects of drug and most of the patients feel happy, relaxed and energetic with improvement in their functional capacity which gave an add on boost to the study. The drug is giving very promising result in a competitive market to conventional health drink.
Keywords: Reproductive; Health; Conventional
Keywords
Reproductive; Health; Conventional
Introduction
The continuum of an individual life can be divided into several life stages each characterised by certain features. Having knowledge of framework of life stages can bring deeper empathic understanding. Accompanied by considerable hormonal changes the life stages of women are generally divided into infancy, puberty, reproductive age, climacteric period and elderly. Health status in a particular stage then influences the next stage. It is important to pay attention to psychological aspects of women's health and reflect such understanding in clinical practice. Within the framework of WHO definition of health as a state of complete physical, mental and social well-being & not merely the absence of disease or infirmity. Reproductive health addresses reproductive processes, functions and system at all stages of life [1]. The reproductive axis is closely linked to nutritional status especially under nutrition in females. food intake, inadequate alimentary regimens, strong dietary restrictions and a general lack of nutrients result in loss of both body weight and physical performance as well as delayed puberty, lengthening of postpartum interval to conception, lower gonadotropin secretion level with alteration of physiological ovarian cyclicity, increase infertility and can worsen the effect of menopausal syndrome [2].
The entire reproductive period of females when divided into two gives a first half with better reproductive potential and a second half where reproductive system functions to help women in leading a healthy personal and family life by providing proper hormonal support.
Various Life Stages
Puberty /adolescence: The first half of this period may specifically be called puberty and second half adolescence [3]. One's sense of values developed during this stage. When a girl changes into women, her nutritional need changes to support growth and development [4]. Approx. 1-5% of women suffer from weight related amenorrhea because many girls with delayed puberty are relatively thin during adolescence it has been suggested that a certain critical body weight is required for onset of cyclical ovarian activity.1
Reproductive age: From late teens to perimenopause in late 40s is a period of sexual maturity also called reproductive age. In this maturation period the psychological changes unique to women are menstruation related disorders and uterine or ovarian diseases [5]. Nutritional needs undergo enormous shift when a woman is in reproductive age to improve quality of their life and to increase survival & healthy development of their child. Menstrual periods often cease after a 10-15% decrease in normal body weight. Menstruation becomes irregular when BMI <19 Kg/m2.
Menopausal age: During this age women tends to loss bone strength, connective tissues, muscle mass & generalised body strength, so they need nutritional support [6]. Up to 100% of circulating oestrogen comes from fat in post- menopausal women (Figure 1).
Posology
Drug Name : Sahasraveeryadi Granules
Constituents : Ashwagandha, Shatavari, Bala, Lodhra For the purpose of
For the purpose of granulation sita was taken
Dosage : 6 gm – 12 gm depending on Bala, desh, kala, prakriti, aging of Patient
Aushadh Sewana Kala : Antrabhakta and Nishakala.
Anupana of drug : Gau dugdh
Route of administration: Orally
Duration of trial : 3 months
Follow up : 15 days
Collection of Data
Patient suffering from general debility and ill reproductive health attending OPD & IPD of Prasuti Tantra & Stree Roga Department of Government Ayurveda College & Hospital, Varanasi will be selected randomly for this clinical study.
The patient will also be selected from special camps organised time to time by PTSR Department.
Material and Methods
Materials
Drug was prepared in the pharmacy of Govt. Ayurveda College & Hospital Varanasi with the help of Ras Shastra Dept.
Selection of cases
The pilot study included twenty female patients with the complaints of generalised weakness, reduced weight and associated gynaecological symptoms coming under inclusion criteria from the O.P.D, Dept. of prasuti tantra and strirog, Government Ayurveda PG College and hospital, Varanasi [7]. Total 20 patients of three age groups (adolescent, reproductive and menopausal age group) were taken randomly for the study and effect of the drug was evaluated on them. Duration of trial was approx. 3 months.
Study Design
Pilot study was done on 20 patients. It was a single arm prospective study done on three age groups of females (adolescents, reproductive, menopausal) selected randomly.
Advices
Patients will be advised some life style modifications: -
Having a healthier, wholesome, fresh, warm & balanced diet.
Sound sleep for 7-8 hours.
Avoid alcohol, smoking and caffeine.
Set aside time for activities that makes you happy.
Yogasanas to improve digestion like Paschimottanasana, Balasana, and Pavanmuktasana etc.
Follow up
Treatment is continued for a period of 3 months. The patient will come for follow up on every 15th day up to 90 days.
Inclusion Criteria
• Patients willing & able to participate in study.
• Female patients of 10-55 years age group.
• Patients whose BMI is from 16.0 to 19.0 kg/m2.
• Patients suffering from mild to moderate nutritional deficiency.
• Patient suffering from any kind of menstrual abnormalities and vaginal discharges because of general debility.
• Patient with peri-menopausal and post-menopausal symptoms.
• Patient with delayed menarche and secondary sexual characters.
Exclusion Criteria
• Patient not willing & not able to participate in study.
• Female patients <10 years & >55 years of age.
• Severe acute malnutrition (SAM).
• Patients having BMI <16.0 Kg/m2 & >19.0 Kg/m2.
• High clinical suspicion of acute & chronic disease like TB, HTN, DM etc.
• Patient suffering from structural abnormalities, systemic, endocrinal, metabolic, chromosomal disorders and any abnormal growth.
• Pregnant and lactating females.
Informed Consent
The purpose of the study, nature of study and potential risks and benefits were explained in non-technical terms. There after their written consent was taken before starting the procedure.
Drug formulation
Churna kalpana of ashwagandha mula, shatavari mula, lodhra twaka and bala panchang were taken in equal quantity. Decoction of these four drugs according to classics was made and sita (mishri1/3 of total drug) was added in it [8]. Then churna prepared was well mixed with this decoction and granulation of drug was done.
Investigations
1. Haematological Studies- CBC, BT, CT, ESR.
2. Serology- VDRL, HBsAg, HCV, HIV1&2
3. Measure Serum LH, FSH, Prolactin.
4. CMP test – Comprehensive Metabolic Panel (LFT, KFT, Blood sugar etc.)*
5. Lipid Panel.
6. Thyroid Profile.
7. USG*
8. Endometrial Biopsy*
9. Urine Analysis- R/M and (C/S)* (* - As needed)
Examination
• General Examination.
• Systemic Examination.
Gynaecological Examination.
Criteria to be followed during study
Subjective criteria
To assess general health of females
Before Treatment
Nutrient intake
o Adequate
o Inadequate
After Treatment
Nutrient intake in past 2 weeks
o Adequate
o Improved but not adequate
o No improvement
Before Treatment
Functional capacity
(Assessed by level of Fatigue and progressive loss of function)
o No dysfunction
o Reduced capacity
After Treatment
Functional capacity in the past two weeks (Tables 1-3).
Criteria | Yes/No |
---|---|
I feel happy & relaxed | |
I feel calm & relaxed | |
I feel energetic | |
When I woke up I felt refreshed and I had enough rest | |
My daily me is full of interesting things |
Table 1: Happiness Scale.
Above 19.0 kg/m2 | 0 |
---|---|
From 17.5- 18.9 kg/m2 | 1 |
From 16-17.4 kg/m2 | 2 |
Less than 16.0 kg/m2 | 3 |
Table 2: BMI (Weight /height2).
Relief in symptoms | Grading |
---|---|
No relief | 0 |
Mild relief | 1 |
Moderate relief | 2 |
Complete relief | 3 |
Table 3: Gynaecological Symptoms.
o Improved
o No change
o Decrease
Final Assessment
• Cured - >90% relief
• Markedly improved- >75-90%
• Moderately improved- >50-75%
• Mild improvement- >
Case Study
Total 20 patients of three age groups from 10 -55 years were taken for study. All of the females are lean and thin with BMI ranging from 16.0 to 19 kg/m2.. Also with that they all were suffering from some kind of gynaecological disorder like delayed puberty, menstrual irregularities, scanty menses, white discharge, menopausal symptoms etc (Table 4).
S.no | Patient's Age | Symptoms | BMI before treatment | BMI after treatment | Relief |
---|---|---|---|---|---|
1 | 22 | Generalised weakness, white thin discharge from 2 months, backache | 18.2 | 19.2 | Got relief |
2 | 28 years | Generalised weakness, scanty menses from 3 cycles , loss of appetite, incomplete bowel clearance | 17.5 | 18.6 | Moderately improved |
3 | 22 years | White thin discharge from 4 months, lower backache, generalised weakness | 17.8 | 19 | Got relief |
4 | 12 years | Pain just before and during menses since menarche, generalised weakness | 16.9 | 18 | Got relief |
5 | 31 years | Heavy bleeding during menses from 6 months, generalised weakness | 16 | 16.8 | Mildly improved |
6 | 26 years | Thick white discharge from 2months, wants to conceive child from 1 year, | 17.6 | 19.2 | Moderately improved |
7 | 13 years | Pain during menses since menarche, generalised weakness | 18.3 | 19.4 | Got relief |
8 | 15 years | Thick white discharge per vagina from 3 and half months, generalised weakness | 18.1 | 19.6 | Markedly improved |
9 | 17 years | White thin discharge per vagina from 1 month associated with pain in lower abdomen, backache, loss of appetite | 16.4 | 18.2 | Markedly improved |
10 | 24 years | Absence of menses from 2 months , history of delayed menses, generalised menses | 17.4 | 19 | Moderately improved |
11 | 18 years | Menstruation has not start yet, ill developed secondary sexual characters, generalised weakness | 16.1 | 18 | Moderately improved |
12 | 48 years | Sleeplessness, lower backache, hot flushes associated with generalised weakness from1 year | 18.2 | 19.6 | Got relief |
13 | 42 years | Irregular menstruation with delayed interval of 40-42 days from 1 years, pain in legs, generalised weakness | 16.9 | 18 | Moderately improved |
14 | 16 years | Excessive pain during menses with scanty flow from 6 months, generalised weakness | 17.3 | 19.2 | Markedly improved |
15 | 50 years | Hot flushes, sleeplessness, lower backache, generalised weakness from 4 months | 18.2 | 19.4 | Moderately improved |
16 | 53 years | Pain in all joints and lower back, generalised weakness from 3 years | 18 | 19.5 | Moderately improved |
17 | 35 years | Mood swings associated with anxiety and headache, irregular menses with reduced interval of 21-23 days from 3 months | 18.4 | 19.6 | Markedly improved |
18 | 28 years | White thick discharge per vagina from 6 months, loss of appetite, reduced functional capacity | 17.2 | 18.8 | Moderately improved |
19 | 21 years | Delayed menstrual cycle with interval of 36-38 days from 2 years, pain during menses White thin discharge per | 17.7 | 19 | Moderately improved |
20 | 30 years | vagina from 15 days , pain in lower back, generalised weakness | 16.4 | 18 | Markedly relief |
Table 4: Case study on 20 patients of their age groups ranges between 10-55.
Results
• Cured – 25 percent
• Markedly improved – 50 percent
• Moderately improved- 95 percent
• Mild relief - 100 percent
Discussion
The significance of the women health cannot be over emphasized as it is very basic for good family life. Females pay very less attention toward their health and many of them are under nourished. Decreased BMI in females leads to various reproductive health issues like delayed puberty, leucorrhoea, disturbance in menstrual cycles, abnormal uterine bleeding, increased peri menopausal symptoms and reduced pain tolerance etc. Good nutritional supports plays an important role in maintaining the basic reproductive health and increasing functional capacity among females by increasing their weight, providing energy and making them feel more relaxed and happy (Figure 2).
Sahasraveeryadi Granules were taken for study containing ashwagandha, shatavari, bala, lodhra and sita to see their combined effect on reproductive as well as general health of females. Granulation is done so that the patient can take the medicine easily with milk. Granules were given twice in a day for three months. The drug works optimistically in improving and maintaining health among females [9].
It reduces all gynaecological symptoms happened because of reduced weight. The patients feel very happy, energetic and relaxed. By using the drug continuously for 3 months the weight of patient increases with the average of 1 kg every fortnight which automatically increase their immunity and pain tolerance.
Conclusion
The study was done on 20 patients between the age group between 10-55 years and whose BMI ranges from 16 to 19 kg/m 2 suffering from mild to moderate nutritional deficiency. Sahasraveeryadi granules were given to patients for 3 months. The drug gives optimistic results on these patients [10]. The BMI of all patients increase with moderate to complete relief in all gynaecological symptoms caused because of nutritional deficiency. During study it was observed that there were no side effects of drug and most of the patients feel happy, relaxed and energetic with improvement in their functional capacity which gave an add on boost to the study. The drug is giving very promising result in a competitive market to conventional health drink.
References
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Citation: Kaila B, Singh S, Mishra S (2022) Clinical Evaluation of Sahasraveeryadi Granules on General and Reproductive Health of Females. J Tradit Med Clin Natur, 11: 332. DOI: 10.4172/2573-4555.1000332
Copyright: © 2022 Kaila B, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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