Department of Post Graduate Studies in Prasooti & Stree-Roga

From,

Dr.BAGALI .C.S

Preliminary M.S (Ay.) Scholar

Department of Post Graduate Studies in Prasooti & Stree-roga

N.K.JCollege of Ayurveda and Hospital

BIDAR

To

The Registrar,

RajivGandhiUniversity of Health Sciences

BANGALORE,Karnataka

Through:

The Principal and Head of Department PG studies Prasooti &stree-roga

N.K.JCollege of Ayurveda &Hospital,Bidar

Subject: Submission of Completed Proforma for Registration of Synopsis of Dissertation

Respected Sir,

I request you to kindly register the below mentioned subject against my name for the submission of the dissertation to the Rajiv Gandhi University of Health Sciences,Bangalore,for partial fulfillment of M.S. (Ayurveda) in Prasooti &Streeroga

The title of dissertation:

“CLINICAL STUDY ON APRAJA Vandhya (primary infertility) by AN INDIGENOUS COMPOUND W.S.R. TO OVULATORY dysfunction”

Herewith I am enclosing completed proforma for Registration of Subject of dissertation

Thanking You

Yours faithfully

(Dr. Smt. Bagali C.S.) Date

Place: Bidar

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES

KARNATAKA-BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1. Name of the Candidate and Address: Dr. (Smt.) BAGALI C.S.

c/o Mr. R.S BAGALI

IBRAHIMPUR .RLY. GATE

VIVEK NAGAR (EAST)

BIJAPUR. –DIST.

KARNATAKA-STATE

2.Name of Institution N.K.J. AYURVED MEDICAL

COLLEGE & POST GRADUATE

CENTRE BIDAR-585 403.

KARNATAKA (INDIA).

3.Course of study and Subject : M.S.

(Prasooti tantra stree- roga)

4.Date of Adimission to Center :31st May 2007.

5.Title of Topic :

“CLINICAL STUDY ON APRAJA VANDHYA (PRIMARY INFERTILITY) BY AN INDIGENOUS COMPOUD W.S.R. TO OVULATORY DYSFUNCTION”

6. Brief Resume Of The Intended Work

6.1 Need for study

Infertility is a major problem in our society. Now a day the rate of infertility is steadily increasing because of change of life style of human beings.

People want to lead luxurious life for that they are running behind the money, and thus people get more stressed and tensed out at work.

Delayed marriage,higher education & high ambitions, which are the cause for infertility.

Today's life is very fast, the food habits are also changed, the intake of fast food, junk food and adulterated food also impacts fertility.

The Incidence rate mentioned by World Health Organization (WHO) reveals that between 2-10% of couples worldwide are unable to conceive primarily .

About 60-80 million couples in the world are infertile .

40-60% of female patients are suffering from infertility with ovulation failure being 20%.1

 The most common cause of female infertility is ovulatory disorder characterized by anovulation or by infrequent and/ or irregular ovulation.

Oligomenorrhoea or complete amenorrhea usually indicates ovulatory disorders2.

A person without a child is like a tree devoid of fruits denotes the importance of treatment of infertility.3

 Primary infertility is a common problem in women encountered by gynecologist

The psychoneurotic upset resulting from infertility affects woman’s physical as well as mental health.

The high incidence of side effects of existing treatment by hormones , needs appropriate, safe, non hormonal approach.

To establish safer Ayurvedic remedy.

6.2 Review of literature

A/C to SusrutacharyaVandhya is a woman who had lost her Artava i.e menstruation. This is interpreted as loss of ovulation means infertility (Artava means ovum)4&5

Pushpaghni Jataharini mentioned by Kashyapa presents with failure of menstruation and androgenic features 6.

Harita explained 6 types of vandhya among these varieties Anapatya, Garbhasravi, Balakshaya are curable after a period of treatment 7.

. Charaka described about Apraja vandhya as complication of yoni –vyapad. It is characterized by failure of conception 8

Charak classified infertility into 3 types :

• Vandhya (congenital absence of Garbhashaya or Artava)
• Apraja (primary infertility )
• Sapraja (secondary infertility )

Previous Works

1. Obeja(mrs)-Clinical study of effect Phala Ghruta in female infertility-1981- B.H.U.
2. Lakshmi.M –clinical management of vandhyatva by oral use of Baladi Choorna with & without Bala taila Uttara basti -1997 -Hyderabad
3. Susmita.P.Otta-Clinical study on the management of female Infertility with Phala Ghritha Uttar basti-2001-U.U.
4. Rajput Artiben N-Comparative study on Shatapuspa and Mishreya on Beejotsarga (ovulation)-2001-G.A.U.,JAMNAGAR
5. Hemalata.C.Kongi –Management of stree vandhyatva (Female infertility) with Ashvagandha-kshirapaka -2003- R.G.U.H.S.

6.3 Objectives of the study.

1. To assess the efficacy of Ayurvedic remedy in the management of infertility
2. To conduct conceptual study of female infertility and to establish the correlation with Apraja vandhya (Primary infertility)

7. Material and method.

7.1 Source of data

1. The present study is a clinical trial. Hence the patients will be selected from N.K.J. Ayurvedic Medical college and P.GCenter attached SriSiddharudhaCharitableHospital and other private hospitals.
2. Ayurvedic classics and Modern scientific books.
3. National and International periodicals and Journals, Paramedical and Science oriented magazines, Research papers and Latest information from Internet .

National and International Seminars

1. Conference and Workshop related to subject
2. Pharmacy attached to college for preparation of medicine
3. Raw drugs are collected from the market under the supervision of dravya guna specialist

Drug Review

7.2 Method of Collection of Data

patients will be selected on simple randomized sampling grounds after proper investigation i.e U.S.G and physical examination according to the selection criteria

Sample size –

30 patients will be selected according to Inclusion criteria,

Patients fulfilling above criteria were assigned in to 2 groups

Group A – 15 patients will be given trial drug Ghanasatwa in a capsule form of 500mg administered orally in a dose of 2 capsule T.I.D with warm milk as anupan for 20 days (from 5th day of menses up to25th day) for 3 cycles

Group B -15 patients will be given placebo for 3 cycle (control group)

Follow up –

Evaluation of symptoms will be done before treatment ,after 1st Cycle ,2nd Cycle & 3rd Cycle .

Methodology The progress will be noted on basis of assessment parameters (both subjective & objective parameters) and noted in specially prepared case sheet.

Statistical analysis

The result will be statistically analyzed by employing some statistical tests between the groups & also within the groups.

1.Within the groups:-

If the observations are paired type (Depending) then to test significant difference between two dependent means or paired means we may use paired ‘t’ test (students ‘t’ test).

The test statistics

t =d √n where d = ∑ d

s

n

d = Difference between before treatment values & after treatment values.

n = Number of observations.

s = Standard deviation of the difference ═

Degrees of freedom = n-1

2.Between the groups:-

For testing the significant difference between two independent means. Student‘t’ test for testing two independent means may be employed.

The‘t’ test statistics is: -

t = Where= ∑ x/n1 x = Treatment group.

= ∑ y/n2 y = Control group.

S = Pooled standard deviation =

n1 = No. of observation in Treatment group.

n2 = No. of observation in the Control group.

Degree of freedom = n1 + n2 - 2

Selection CRITERIA

Inclusion Criteria:-

1. Married women of age group between 20 to 35 yrs
2. Patients having symptoms of Apraja vandhya (Primary infertility)
3. Scanty,Irregular periods with anovulation

Exclusion Criteria

1. Patients suffering from STD, HIV, and Hepatitis B
2. Patients suffering from any Systemic disease like D.M,T.B
3. Hyper & Hypothyroidism
4. Patients with severe anemia
5. Secondary infertility
6. Nephritis

Diagnostic Parameters for Assessment

Subjective Parameters:-

1. Irregular and scanty menstrual history
2. Primary Infertility

Objective Parameter

1. B.B.T
2. Cervical mucus study
3. Sonography(Follicular Study)

7.3 Does the study require any investigation or intervention to be conducted on patients or other humans or Animals ? If so please describe briefly.

• Medicine is directly tried on the humans.
• All the patients selected will be subjected to the following investigation
• Hb%
• WBC(T.L.C. & D.L.C.)
• E.S.R
• Urine (R and M)
• Hormonal assay(If needed)

7.4HAS ETHICAL CLEARANCE BEEN OBTAINED FROM THE INSTITUTION? Yes

8. LIST OF REFERENCES

1Geeta Belleppa , Anuradha ,Nilini Baiia ,V.Vijaya Kumar-The Role of Herbal Druge in Infertile Couples – Obj & Gynae –Today Monthly Journal -2003 –Vol No VII 5 May P.P 281

2D.C Dutta –Text book of Gynaecology .-NEW CENTRAL BOOK AGENCY (P) LTD 8\1 CHINTAMANI DAS LANE , CALCUTTA 700 009 (INDIA) – 2005 – PP -214

3Pt Kasinath Shastri & Gorakha Natha Chaturvedi –Charak Samhita of Charak Vol II Chaukhamba Bharati Academy –Varanasi -2004 –PP 38

4Kaviraj Ambikadutta Sastri –Susruta Samhita of Maharsi –Susruta –Vol –II-Chaukhamba Sanskrit sansthan- Varanasi -2003-PP-157

5Kaviraj Ambikadutta Sastri –Susruta Samhita of Maharshi-Susruta –Vol-I – Chaukambha Sanskrit Sanstan-Varanasi -2003 -PP-59

6Prof.(Km)P.V.Tewari –Kasyapa Samhita or Vrddhajivakiya Tantra Chaukhambha Visva Bharti –Varanasi-2002-357&358

7Pt Hariprasad Tripati –Harita Samhita –Chaukhambha Krishnadas Akademy –Varanasi-2005 PP-448 & 449

8Pt Kasinath Sastri & Dr Gorakha Natha Chaturvedi –Carak Samhita of Charak Part I(vol-I) ChaukhambhaBhartiAcademy –Varanasi -2005 -877

9. SIGNATURE OF THE CANDIDATE:

10. REMARKS OF THE GUIDE:

11. NAME & DESIGNATION OF

(In block letters)

11.1Guide : Prof. DR. PRABHA SHARMA

M.D.(P.T.S.R.) Ph.D. (B.H.U.)

Professor

11.2 Signature:

11.3Co-Guide:DR. SUSMITA PRIYADARSHINEE. OTTA

B.A.M.S.,M.S.(AY.) (P.T.S.R.)

Asst. Prof.

11.4Signature:

11.5Head of Department: Prof. DR. PRABHA SHARMA

M.D.(P.T.S.R.) Ph.D. (B.H.U.)

11.6Signature

12.

12.1 Remarks of the Chairman & Principal

12.2Signature