RESEARCH QUESTION :

What is the effect of Multi-modal Ayurvedic Treatment Protocol in the management of Polycystic Ovary Syndrome (PCOS)?

HYPOTHESIS :

NULL HYPOTHESIS : (H₀)           

There is no effect of Multi-modal Ayurvedic Treatment Protocol (Udvartana with Kolakulathadi Churna, Sarvang Bashpa Swedana with Dashmool Kwath and Pachana with Vaishvanar Churna , followed by Koshta Shudhi with Gandharvhasta Taila followed by Yoga Basti with Bhadradi Kwath and Vidangadi Taila followed by Nasya with Kalyanaka Ghrita followed by Shamana Chikitsa with Hingvashtak Churna and Dashmool Kwath) in the management of Pushpaghni Jataharini (Polycystic Ovary Syndrome).

ALTERNATE HYPOTHESIS : (H₁)

There is significant effect of Multi-modal Ayurvedic Treatment Protocol (Udvartana with Kolakulathadi Churna, Sarvang Bashpa Swedana with Dashmool Kwatha and Pachana with Vaishvanar Churna, followed by Koshta Shudhi with Gandharvhasta Taila followed by Yoga Basti with Bhadradi Kwath  and Vidangadi taila followed by Nasya with Kalyanaka Ghrita followed by Shamana Chikitsa with Hingvashtak Churna and Dashmool Kwath) in the management of  Pushpaghni Jataharini (Polycystic Ovary Syndrome).

NEED OF THE STUDY

1.     Polycystic ovarian syndrome is a most prevalent endocrinopathy. Now a days because of sedentary lifestyles, incidence of this disease is very high. High prevalence not only among reproductive age, but also among adolescents.

2.     Patients with PCOS are at risk of developing Hypertension, Diabetes mellitus, obesity, anovulation and Infertility, Endometrial carcinoma, cardiovascular disease. 20% of women with PCOS develops non-insulin dependent diabetes mallitus (NIDDM) by the age of 30 years¹¹.

3.     No permanent treatment is found for PCOS in modern therapy. The treatment given is symptomatic and duration remains for a longer period. The treatment module includes oral contraceptive, hormonal supplementation, ovulation induction drugs, antiestrogenic etc., which given for long term can produce severe ill effects on the body. Surgical drilling is one of the treatments given, but even its effect is also temporary.

4.     Application of Ayurvedic principles on the pathology involved, reveal a distinct vitiation of Vata. As it is the motive force behind the function of elimination or retention of mala, mutra, artava. Vata can be possibly normalized using the gold standard of Vata treatment – the ‘Basti Chikitsa’. Nasya (intranasal drug therapy) is known to be highly efficient on the central nervous system and regulate the H-P-O Axis, which is dysregulated in PCOS.

5.     Many clinical studies have been conducted to evaluate the efficacy of various aspects of Ayurvedic drugs and panchakarma procedures in the management of PCOS. But hardly an attempt is made for making an effective Ayurvedic Treatment Protocol that is both effective and safe in the management of PCOS. Thus making this study a novel. Hence the proposed study has been planned to establish a fix standard Ayurvedic treatment protocol.

6.     Due to limitation of medical therapy as well as surgical interventions, it becomes the necessity of time to find out a permanent, easy, effective and less side effect producing care which can be easily administered and accepted by the patient. The reason we are doing this research is to develop safe, non invasive, conservative and non hormonal treatment for PCOS.

AIMS & OBJECTIVES:

 AIM :-

· To establish an Ayurvedic standard treatment protocol for management of PCOS.

OBJECTIVES :-

PRIMARY OBJECTIVE  

To evaluate the effect of Ayurvedic treatment protocol on –

§     Polycystic ovaries in USG findings (in unmarried).

§     Follicular growth and ovulation (in married).

SECONDARY OBJECTIVE

To estimate the combined effect of Ayurvedic treatment protocol on -

â–ª Menstrual irregularities.

â–ª On the recovery of Acne, Hirsutism, Acanthosis nigricans, BMI, Weight reduction.

â–ª Improvement of quality of the life (PCOS QOL)

EXECUTION OF THE PROPOSED CLINICAL STUDY STUDY

STUDY TYPE: Non Randomized Clinical Trial

STUDY DESIGN: Interventional study

GROUPING: Single Arm

MASKING: Open Label

TIME: Prospective

STUDY SETTING: The OPD’s and IPD’s of AIIA

SAMPLE POPULATION: Patients from institutional hospital 

CONCEALMENT: Through Registration / UHID NO

SAMPLE SIZE CALCULATION:

Ø Study aims to see the positive changes based on USG in the patients of PCOS due to Ayurvedic Treatment Protocol proposed.

Ø  It is believed, since Panchakarma procedures are the part of the protocol, positive developments will definitely occur and it is assumed that in 80% of the cases positive improvement may occur.

Ø Assuming- Power of  Test as 80%, Level of Significance as 5% and one-sided test, the calculated sample size is 17. Assuming 10% dropouts study should include 20 patients.

Ø

 INCLUSION CRITERIA

1.     Reproductive Age Group: 16-40 years (both married/unmarried).

2.     Patients with clinical features of PCOS like-

 â€¢ Amenorrhea or Oligomenorrhoea  

• Infertility

ʉۢ Anovulation

ʉۢ Acne

ʉۢ Hirsutism

ʉۢ Acanthosis nigricans

3.     Along with confirmed any one Polycystic Ovary in USG finding.

4.     Patients fit for Basti and Nasya karma.

5.     ICD - 11 Code:   5A80.1 Polycystic ovary syndrome

EXCLUSION CRITERIA

1.     Primary amenorrhoea.

2.     Pregnancy

3.     Pelvic diseases like (Endometriosis, Hydrosalphinx, Fibroid uterus etc) causing Oligomenorrhoea and Anovulation.

4.     Organic lesions of reproductive tract like T.B, Carcinoma and congenital deformities.

5.     Hyperprolactenemia due to Pituitary Adenoma.

6.     Cushing’s syndrome

DIAGNOSTIC CRITERIA-

 Rotterdam criteria 2003 (2 out of 3 symptoms if present)

1. Anovulation or Oligo-ovulation .

2. Hyperandrogenism-

a) Clinical -Acne, Hirsutism, Acanthosis Nigricans

b) Biochemical- (elevated S.testosterone ).

3.  PCOS features on USG (  12 Follicles of 2- 9mm in size in each ovary  or ovarian volume >10 cc.)

STUDY DURATION

·       Duration of Intervention – 64 Days

·       Duration of Follow Up – 30 Days

·       Total Duration of Clinical Study– 94 Days

INVESTIGATION –

 *Blood investigations will be done on 2^nd or 3^rd day of menstrual cycle.

Ultrasonography:

·       USG-Trans-vaginal (TVS)  in married patients.

·       USG-Pelvis in unmarried patients.

USG protocol adopted for the study:

1. USG will be done on 2nd or 3rd day of menses for diagnosis of PCO.

2. USG for follicular growth, maturity and ovulation will be done on alternate days from

09^th to 19^th  day.

CRITERIA FOR ASSESSMENT

Assessment has done based on both subjective and objective parameters.

Subjective Parameters:

The improvement in the patient was assessed mainly on the basis of relief in the signs and symptoms of PCOS like Menstrual pattern (duration, interval, amount of blood loss), Hirsutism, Acanthosis nigricans, Acne, BMI, Weight Reduction.

Objective Parameters:

• USG (Pelvis/TVS)

• Hormonal Assay

• Reduction in the ovarian volume .

• Ovulation, improvement in growth and development of follicle.