Dr. Shikha Shukla

From,

DR. SHIKHA SHUKLA

Preliminary M. S. (Ayu) Scholar,

Department of Post Graduate Studies in Stree roga & Prasuti tantra

N.K.J.A.M.C. & P.G. Centre,

BIDAR- 585403.

To,

The Registrar,

Rajiv Gandhi University of Health Sciences,

BANGALORE, Karnataka.

Through,

The Principal and Head of Department of P.G. studies in Stree roga & Prasuti Tantra

N.K.J.A.M.C. & P.G. Centre,

BIDAR -585403.

Subject: Submission of Completed Proforma for Registration of Synopsis for 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. (Ayu) in Stree roga & Prasuti Tantra

TITLE OF DISSERTATION:

“ROLE OF JALAKUMBHI IN UTERINE FIBROIDS.”

I am enclosing completed Proforma for Registration of Subject for dissertation.

Thanking You,

Yours faithfully,

(DR. SHIKHA SHUKLA)

Date:

Place: Bidar.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

01. Name of the Candidate and Address (in block letters)

/ : / DR. SHIKHA SHUKLA
D/O DR. S.N. SHUKLA 944, INDIRA NAGAR
DEHRADUN – 248 006 (UTTARAKHAND)
02.Name of Institution / : / N.K.J. AYURVEDIC MEDICAL COLLEGE AND P.G.CENTER, BIDAR(Karnataka)
03 Course of Study and
Subject / : / MS(PRASUTI TANTRA
AND STREE ROGA )
04. Date of Admission / : / 9th JUNE ‘ 08
05. Title of Topic / :
“ROLE OF JALAKUMBHI IN UTERINE FIBROIDS.”

6. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY:

Ø In present times, there is a steady rise in gynecological disorders. Among these uterine fibroids have got an important place.

Ø Uterine fibroids are not only the commonest benign tumour of the uterus but are the commonest benign solid tumour in female.it has been estimated that at atleast 20% of women of 30 have got fibroid in their wombs. Fortunately, most of them remain asymptomatic. The incidence of symptomatic fibroid in OPD is about 3%.These are most common in nulliparous or in those having one child infertility. The prevalence is highest between 35-45 years. 1

Ø As uterine fibroids are seen mostly during prime working years, they negatively impact women’s ability to work. Work absence has been reported by 40% of women. Symptoms like heavy bleeding, pain in abdomen, bladder irritability, etc interfere with home, social & work life of women due to tiredness, weakness, lack of control & unpredictability

Ø Around 68-70% of women undergo surgical procedures to treat uterine fibroid each year, and these involve extensive absenteeism from day to day life. These current treatment options place an undue burden on women. Thus, now, women are looking for non invasive treatment methods which do not require hospitalization & lengthy recovery.

Ø This is where an ayurvedic approach is needed. From the different drugs mentioned from ayurvedic classics, Jalakumbhi (Pistia stratiotus) is selected for this research work.

6.2 REVIEW OF LITERATURE:-

a) uterine fibroid is mentioned in Text Book of Gynecology, Dutta.1

b) Mansaj Granthi described in Charak Samhita can be compared to uterine fibroid.2

c) Sushrutacharya has mentioned Granthi & its treatment. 3

d) Reference of Mansaj Granthi and its treatment is seen in Ashtang Hruday and Ashtang Sangrah. 4,5

e) Chakradatta and Bhavprakash have also mentioned about Granthi. 6,7

f) Reference of Granthi is also seen in Madhukosh Tika, and Chakrapani Tika.8,9

g) Gadnigraha , and Vangsena has also described Granthi.10,11

h) References of drug are found in Chakradatta, Bhavprakash, Bhavprakash Nighantu, Kaidev Nighantu, Dravyaguna Vigyan (Dr. P.V. Sharma) and Dravyaguna Vigyan (Gyanendra Pandey) and in Plants That Heal (Dr. J.C. Kurian).12,13,14,15,16,17,18

6.3 OBJECTIVES OF STUDY:

1. To decrease the fibroid size & relieve the symptoms.

2. To evaluate efficacy of Jalakumbhi on the treatment of uterine fibroids.

7. MATERIALS & METHODS:

7.1 SOURCE OF DATA:

1. Patients will be selected from the O.P.D of Prasuti Tantra & Streeroga of Sri Sidharoodha Charitable Hospital attached to N.K.J Ayurvedic Medical College & P.G Center, Bidar, Karnataka & other associated Hospitals of city.

2. Samhitas, Nighantus & Modern books of Gynecology, Medicine, Physiology & Pharmacology.

3. Pharmacy attached to the college for preparation of drug.

The raw drugs will be collected from local market under guidance of Rasashastra & Dravyaguna specialist & prepared in the pharmacy of the college.

DRUG REVIEW

Jalakumbhi12,13,14,15,16,17,18

(Pistia stratiotus)

Family : ARACEAE

Rasa : Tikta, Madhur

Vipaka : Madhur

Veerya : Sheeta

Guna : Laghu,Ruksha

Doshkarma : Tridoshashamak

Parts used : Panchang

Dosage : Churna 6 gm BD
7.2 METHOD OF COLLECTION OF DATA:-

Being a clinical study, patients will be selected on simple randomized sampling grounds after proper investigation & physical examination according to selection criteria.

Sample Size: 30 patients will be selected according to inclusion criteria, patient fulfilling above criteria will be assigned in 2 groups.

Sample Procedure: The study is single blind clinical study in which 30 patients will be selected on the basis of simple randomized sampling procedure & will be divided into 2 equal groups.

Group A (Treatment group):

15 patients will be given trial drug (churna of Jalakumbhi) in a dose of 6 gm BD for 2 months.

Group B (Placebo group) :- 15 Patients will be given placebo for 2 months.

INCLUSIVE CRITERIA:-

Age 25 -45 yrs
Single or multiple uterine fibroids
Size upto 8 cms
Submucous fibroids

EXCLUSIVE CRITERIA:

Intramural fibroids
Subperitoneal fibroids / Subserous fibroids
Broad ligament fibroids
Pedunculated fibroids
Pregnancy
Systemic diseases
Malignant disorders

SUBJECTIVE PARAMETERS:

§ P.V. Bleeding

§ Menstrual abnormalities

§ Pain in lower abdomen

§ Backache

OBJECTIVE PARAMETERS:

§ Number of fibroids

§ Size of fibroids

§ Pads used per day

STATISTICAL ANALYSIS

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

The observation will be analyzed critically & scientifically .The result will be evaluated for its significance .If needed Chi square test can be used.

FOLLOW UP : Two follow ups , one at the end of each month.

7.3 INVESTIGATIONS REQUIRED:

1. CBC

2. USG FOR SIZE & LOCATION ( AS DIAGNOSED BY USG)

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR

INSTITUTION : Yes Obtained

8. List of references:

1. Acharya Priyavata Sharma and Dr. Guruprasad Sharma, Kaidev Nighantu, Chaukhambha Vishwabharati, Varanasi, 1979, 1st edition, P.P 271, 272

2. Charak Samhita Chikitasthan 12/81 Teka Chakrapanidutta, Chaukhambha Publication, New Delhi, 2001, 5th edition P.P 489.

3. Dr. J.C Kurian. Plants that Heal Publication G.S Robest Clive at and for Owners Oriental watchman publishing House, Pune, 2003, 5th edition, P.P. 225, 252.

4. Dr. Tripathi Indradeva, Gadnigraha Shalyatantra, 4th Khand Vol III 2-8, 100, 101, Chaukhambha Sanskrit Sansthan, Publishers & Distributors Oriental Cultural Literature, Varanasi, 3rd edition, P.P 243,

5. Ganga Sahaya Pandey and Krishna Chandra Chunekar, Bhavprakash Nighntu, Chaukhambha Bharati Academy Publisher and Distributor of Monumental Treatises of the East, Varanasi, Reprint 2006, P.P. 485, 486

6. Gyanendra Pandey, Dravyaguna Vigyan Vol I, Chaukhamba Krishnades Academy Varanasi 1905, 3rd edition P.P 815, 816, 817, 818

7. Kavivar Shri Shaligramji Vaishya and Shri. Vaidya Shankarlalji Jain, Vangsena, Granthiroga Adhikar, Khemraj Shri Krishnadas Prakshan, Mumbi, 1996, P.P. 552, 553, 554, 555

8. P.V. Sharma, Chakradatta 41/6, Chaukhambha Publishers, Varanasi, 1902 3rd edition, P.P 342

9. Prof. K.R. Shrikantha Murthy, Bhavprakash of Bhavmishra,Vol II, 44/29,Chowkhamba Sanskrit Series Office, Publishers and Oriental and Foreign Book, Publishers and Oriental Sellers, Varanasi, 2005, 3rd edition, P.P 540

10. Prof. P.V Sharma, Dravyaguna Vigyan Vol II, Chaukhambha Bharati Academy, Publishers and Distributors of Monumental Treatises of East, Varanasi, Reprint 2003, P.P. 796, 798.

9. SIGNATURE OF THE CANDIDATE :

10. REMARKS OF THE GUIDE :

11. NAME & DESIGNATION OF

(In block letters)

11.1 Guide: DR. L.V. RATHNAKAR

M.D. (PSB); B.H.U.

ASSOCIATE PROF. P.G. DEPT.

PRASUTI TANTRA & STREE ROGA

11.2 Signature :

11.3 Co-Guide :

11.4 Signature :

11.5 Head of Department : Prof. Dr. PRABHA SHARMA

M.D.Ph.D (BHU)

PROFESSOR & HOD . P.G. DEPT.

PRASUTI TANTRA & STREE ROGA

11.6 Signature :

12. 12.1 Remarks of the Chairman & :

Principal

12.2 Signature :