A Randomised Comparative Clinical Study to Evaluate the Effect of Millet Based Diet Module and Yoga Capsule in Nashtartava With Special Reference to Polycystic Ovarian Syndrome PCOS

NEED OF STUDY :

Polycystic ovarian syndrome (PCOS) is the commonest endocrinopathy among women of

reproductive age with an estimated prevalence of about 10% and high among Indian women.

Many research es ha ve been conducted regarding th is issue but with no patient have be e n

cured. In modern system of medicine many conventional therapies i.e oral contraceptives,

ovulation induction agents, progest i n anti a ndrogen and surgical intervention a re main

standard therapies for this disease but having a number of side effect therefore there is

increasing demand to correct this problem has le d to find cure in other science. Ayurveda

being the ideal ancient science seem to have its solution as there is a description of

Nashtaartava / PCOS in Ayurveda (Yonivyapada ).

In this stu

dy Aahar and Vihar have been focus because PCOS is an lifestyle disorder it can be

cure by Simple lifestyle intervention which includes A ahar Vihar . In Aahar millets play a

major role . M illets are high in fibre & complex carbohydrate with a low glycemic index,

useful in weight management. In ViharVihar, Yoga is included as Yoga can reduce the symptom

associated with this disorder. Yoga is a non invasive intervention which will not only focus

on physical health but also mental health.

In this study

A har a and V ih ara has been focussed over classical ayurvedic chikitsa upkrama

because shodhana karma required long duration of admission of patients and shaman karma

at OPD level is often non palatable to the patient

ThusThus, it is necessary to modulate a well accepted ayurvedic approach toward this

multifactorial & heterogeneous disease.

RESEARCH QUESTION:

• Whether Millets Base Diet is more effective than Yoga Capsule in polycystic ovarian syndrome (pcos) w.s.r Nashtartava.

HYPOTHESIS:

Null Hypothesis [H

O

There is no difference in efficacy of Millet-Based Diet and Yoga Capsule in PCOS w.s.r.to Nashtartava.

Alternative Hypothesis [H

1

There is difference in efficacy of Millet-Based Diet and Yoga Capsule in PCOS w.s.r. to Nashtartava.

AIMS AND OBJECTIVES:

AIMS AND OBJECTIVES:

AIM:

1. To evaluate the role of millet- based diet module and yoga capsule in the management of PCOS w.s.r. to Nashtartava.

OBJECTIVES:

Primary objective:

1. To evaluate the efficacy of millet-based diet in the management of in PCOS w.s.r. to Nashtartava.

2. To evaluate Yoga Capsule in the management of in PCOS w.s.r. to Nashtartava.

Secondary objective:

a) To compare the efficacy of Millet efficacy of Millet--Based Diet and Yoga Capsule in the management of Based Diet and Yoga Capsule in the management of in PCOS w.s.r. to Nashtartava.in PCOS w.s.r. to Nashtartava.

b)

b) Changes in PCOS features (i.e acne, hirsutismChanges in PCOS features (i.e acne, hirsutism, obesity) , obesity) cc) Changes in) Changes in LH:FSH ratioLH:FSH ratio dd) To assess improvement in quality of life) To assess improvement in quality of life

MATERIAL AND METHODS: For present study two types of material were utilized as furnished below: 1. Literary Review:

Literary references will be collected from Ayurveda classics, commentaries, modern literature, research journals available in institute library, online portals like PubMed Central, AUYSH Research Portal, Google scholar and analysed to frame conceptual work. 2. Clinical Study:

• Total duration of studyTotal duration of study: 18 mo: 18 monthsnths

• Recruitment PeriodRecruitment Period: 12 months: 12 months

• Treatment PeriodTreatment Period: : 88 weeks.weeks.

• FollowFollow--Up PeriodUp Period: : After completion of the trial case will be followed after one month

RESEARCH DESIGN:

RESEARCH DESIGN:

• Type of studyType of study: : Interventional Interventional Clinical TrialClinical Trial

• Study DesignStudy Design: Randomized Clinical Trial: Randomized Clinical Trial

• Randomization TechniqueRandomization Technique:: Computer generated random number Computer generated random number

• Allocation ConcealmentAllocation Concealment:: SNOSE (SNOSE (Sequential Number Opaque Sealed EnvelopSequential Number Opaque Sealed Envelopee))

• BlindingBlinding: Open Label: Open Label

• Sample sizeSample size: : 2020 cases in each group are planned to be included in the clinical trial.cases in each group are planned to be included in the clinical trial.

• Number of Number of GroupsGroups: Two groups: Two groups

• Source of data (Population of Source of data (Population of InterestInterest) ) -- Patients fulfilling the inclusion criteria from OPD and IPD of Department of Prasuti & Striroga and Swasthavritta & Yoga, National Institute of Ayurveda, Jaipur will be recruited in the study.

SELECTION CRITERIA

Patients attending the OPD and IPD of Department of Prasuti & Striroga and Swasthavritta & Yoga, National Institute of Ayurveda, Jaipur will be screened on the basis of following criteria

INCLUSION CRITERIA PCOS patients with age between 16-35 years suffering from any of the two features in the following, a) Duration of flow less than 2 days. b) Interval between 2 cycles exceeding more than 35 day. c) Patient suffering from 2 consecutive cycle with oligomenorrhoea and/or anovulation. d) Patients having hirsutism. e) Patients having BMI more than 23 – According to Asian BMI criterion. f) At leastAt least oone ovary showing PCO (diagnosed by USG) [criteria for PCOD, 2003)ne ovary showing PCO (diagnosed by USG) [criteria for PCOD, 2003) ESHREESHRE // ASRMASRM -- Rotterdam revised criteria forRotterdam revised criteria for PCOS 2003]PCOS 2003]..

EXCLUSION CRITERIA a) Pregnant women. b) Patients with BMI less than 19.

c) Patients suffering from any systemic disease.

d) Lactating mothers. e) Woman taking Oral contraceptive pillsOral contraceptive pills.. f) HB level less than 7 gm%

WITHDRAWAL CRITERIA

• During the course of trial if any serious condition or any serious adverse effects occur which require urgent treatment.

• Patients herself wants to withdraw from the clinical trial.

DROP OUT

• Any major illness requiring any intervention or any serious side effect

• Deterioration of condition

• Death due to other causes

• Lack of cooperation by the patient

• Lost from observation

• Patient does not want to continue trial

DETAILS OF INTERVENTION:

Group A

Group B

Intervention

Millet base diet module

Yoga Capsule

Duration

8 weeks

8 weeks

Dose

Dietary preparations of Bajra in morning and Shamaka in evening

1 hour daily in the morning

 Quantity of diet according to Agni

 Diet Samaskar according to season

 Rajaswala charya will be advised to samples of both the groups

YogaCapsuleCapsule:12

Postures

Yoga Practices

Duration(60 min)

Loosening exercise

Titaliasana (Butterfly pose),Chakkichalanasana

5 min

Standing Series

Tadasana, Trikonasana, Veerabhadrasana

7 min

Sitting series

BaddhaKonasana, Ushtrasana,

5 min

Prone series

Bhujangasana, Shalabhasana, Makarasana

7 min

Supine series

Uttanapadasana, Sarvangasana, Halasana, Matsyasana

10 min`

Pranayama

Nadisuddhi Pranayama, Surya Anuloma-Viloma, Kapalabhaati, Bhastrika, Pranayama, Ujjai Pranayama, Bhramari

10 min

Relaxation

Meditation (Om Meditation)

6 min

Deep relaxation technique

10 min

DIAGNOSTIC CRITERIA

All the patients confirming the above said inclusion criteria were included in the study and subjected to thorough interrogation, physical and Sonographical examinations. Patients were selected on the basis of their clinical presentation particularly related to menstruation, features of hyper-androgenism and on the basis of Ultra Sonography (USG) with the report of unilateral or bilateral PCO and or anovulation. Hormonal assessment was carried out only to support the diagnosis, not as diagnostic criteria

INVESTIGATIONS

1. Before Treatment and AfterAfter TTreatmentreatment - a) USG - Uterus & adnexa on 2nd&3rd day of menses. b) Hormonal test - on 2nd& 3rd day of menses.

i. Serum FSH (Follicle stimulating hormone)

ii. Serum LH (Luteinizing hormone)

ASSESMENT CRITERIA

1. Assessment of Menstrual cycle

S.N.

Assessment Criteria

Grade 0

Grade 1

Grade 2

Grade 3

1

Interval between two menstrual cycles

21-35 days

36-39 days

40-45 days

45 days

2

Duration of menstrual bleeding

4-7 days

3 days

2 days

1 day

3

Quantity of menstrual bleeding

2 pads/day

2 pads/day

1 pad/day

Spotting

4

Pain during menses

No pain

Mild

Moderate

Severe

2.Assessment of Hirsutism (Ferriman& Gallwey Scoring system)

1 Upper lip

1 Upper lip 4 Upper back 4 Upper back 7 Lower abdomen 7 Lower abdomen

2 Chin

2 Chin 5 Lower back 5 Lower back 8 Arm 8 Arm

3 Chest

3 Chest 6 Upper abdomen 6 Upper abdomen 9 Thigh 9 Thigh

Hirsutism is classified in terms of the distribution and degree of hair growth through

Hirsutism is classified in terms of the distribution and degree of hair growth through pictorial scales. A score of 1 to 4 is given for nine areas of the body. A total score less than 8 pictorial scales. A score of 1 to 4 is given for nine areas of the body. A total score less than 8 is consiis considered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 dered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.

3.Hirsutism score:Hirsutism score:

Hirsutism

Score

Grade

Non hirsute

<8

1

Mild Hirsutism

8-16

2

Moderate Hirsutism

17-25

3

Severe Hirsutism

25

4

4. Acne Score:

S.N.

Acne Symptoms

Grading

1

No acne

0

2

Comedones and occasional small cysts confined to the face

1

3

Comedones with occasional pustules and small cysts confined to the face

2

4

Many comedones and small and large inflammatory papules and pustules, more extensive and but confined to the face

3

5

Many comedones and deep lesions tending to coalesce and canalize, and involving the face and the upper aspects of the trunk

4

5. Reduction in BMI

6. Serum LH FSH ratio 7. To assess improvement in quality of life. WHO-QOL