From,

DR.PRAGATI TYAGI

Preliminary M. S. (Ayu) Scholar,

Department of Post Graduate Studies in Prasuti Tantra and Stree Roga.

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

BIDAR- 585403.

To,

The Registrar,

RajivGandhiUniversity of Health Sciences,

BANGALORE, Karnataka.

Through,

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

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 Prasuti Tantra and Stree Roga.

TITLE OF DISSERTATION:

“A CLINICAL STUDY ON PREVENTION OF PRETERM LABOUR WITH AN INDIGENOUS COMPOUND.”

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

Thanking You,

Yours faithfully,

(DR.PRAGATI TYAGI)

Date:

Place: Bidar.

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE & ADDRESS: Dr. Pragati Tyagi

W/o Dr. Rajeev Kumar Tyagi

s e -378 Shashtri Nagar

Ghaziabad, Uttar pradesh

Pin Code – 201001.

2. NAME OF THE INSTITUTION : N.K.Jabshetty Ayurvedic

Medical College & P.G

Centre Bidar, Karnataka

3. COURSE OF STUDY & SUBJECT : M.S. (PRASUTI TANTRA

AND STREE ROGA)

4. DATE OF ADMISSION : 11th JUNE 2008.

5. TITLE OF TOPIC :

“A CLINICAL STUDY ON PREVENTION OF PRETERM LABOUR WITH AN INDIGENOUS COMPOUND.”

6. BRIEF RESUME OF INTENDED WORK

6.1 NEED FOR THE STUDY

Spontaneous preterm birth before 37 weeks gestation occurs in 7-11% of pregnancies and before 34 weeks gestation in 3-7% of pregnancies. Preterm delivery particularly that before 34 weeks gestation accounts for three quarters of neonatal mortality and half of long term neurological impairments in children, including developmental delay.1

Preterm labour is defined by the World Health Organization as the onset of labor prior to the completion of 37 weeks of gestation in a pregnancy beyond 20 weeks of gestation. The period of viability varies in different countries from 20 to 28 weeks depending on the facilities available for new born care and the likelihood of survival.2

Any endeavor to reduce the prenatal mortality calls for a successful effort to reach the problem of preterm birth, for no single obstetrical misfortune is more wasteful as prematurity. Half of all neonatal mortality occurs in preterm infants. Inspite of major advances in obstetrics and neonatal care, there has been no decrease in the incidence of preterm labour over half a century. On the contrary, it has been increasing in the developed countries, as more and more high-risk mothers dare to get pregnant.

In Ayurvedic classics many formulations are described for treatment of chalitagarbha in each month of pregnancy. Prevention of preterm labour does not only decrease the mortality and morbidity rate of mother and fetus but also decrease the cost of acute hospital care for preterm infants. Hence, in this present study the efficacy of an indigenous compound is being evaluated, aiming at prevention of preterm labour.

6.2 REVIEW OF LITERATURE:

1. According to Yogaratnakar in Strigarbharoga Nidanam 15,16 there is an indigenous compound mentioned for treatment of chalitagarbha in 7th months of pregnancy.3

  1. Acharya Harita4, Bhavprakasha5 and Vangsena6 has mentioned different oral medicines in treatment of chalitagarbha in every month of pregnancy till 8th month.
  2. The preterm labour can be related to viprasava7 according to Madhukosha commentary on Madhav Nidana and akalaprasava8 according to Arundatta commentary.
  3. The preterm infant can be related to heenang9 according to Kashyap, achirjata10 according to Chakrapani commentary on charak samhita and alpayu balaka11 according to Sushruta.

PREVIOUS WORK:

No previous study is done on prevention of preterm labour.

6.3 OBJECTIVES OF THE STUDY:-

  1. To delay the labour to allow maximum growth and maturity of the fetus and to hopefully reduce prenatal mortality and morbidity.
  2. To assess the efficacy of an indigenous drug in prevention of preterm labour.

7. MATERIALS AND METHODS.

7.1 SOURCE OF DATA

  1. Patient will be selected from Sri Siddharoodha charitable hospital, attached to N.K.J. Ayurvedic medical college & PG center Bidar, Karnataka
  2. Samhitas, Nighantus & modern books of gynecology, obstetrics, medicine, physiology and pharmacology.
  3. Journals (AJOG, BJOG, FOGSI) magazines, seminars, conferences, digital library & web sites.
  4. Pharmacy attached to the college for the preparation of drug.
  5. The raw drugs will be collected from local market under guidance of Dravyaguna specialist & prepared in the pharmacy of the college under the supervision of Rasashastra specialist.

DRUG REVIEW

S.
No. / Drug Name / Latin name / Family / Gunakarma / Doshakarma
1. / Usira / Vetiveria
zizanioides / Poaceae / Rasa – Tikta, madhura
Virya – Seeta
Vipaka – Katu
Guna – Ruksha, Laghu / Kaphapittasamaka
2. / Gokhusra / Tribulus
terrestris / Zygo -- phyllaceae / Rasa – Madhura
Virya – Seeta
Vipaka– Madhura
Guna – Guru, Snigha / Vatapittasamaka
3 / Musta / Cyperus
rotundus / Cyperaceae / Rasa – Tikta, Katu, Kashaya Virya – Seeta
Vipaka– Katu
Guna – Laghu, Ruksha / Kaphapittahara
4. / Samanga / Mimosa
pudica / Mimosaceae / Rasa – Kashaya, Tikta Virya – Seeta
Vipaka – Katu
Guma– Laghu, Ruksha / Kaphapittahara
5. / Nagkeshar / Mesua
ferrae / Gutti ferae / Rasa – Kashasya, Tikta Virya– Usna
Vipaka – Katu
Guna – Ruksa,Tikshna,Laghu / Kaphapittahara
6. / Padmaka / Prunus
puddum / Rosaceae / Rasa – Kashaya, Tikta
Virya – Seeta
Vipaka – Katu
Guna – Laghu / Kaphapittasamaka

Anupana is with honey and water.3

METHODS OF COLLECTION OF DATA:-

(Including sampling procedure, if only) Being a clinical study patients will be selected on simple randomized sampling grounds after proper investigation and 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 to 2 groups. Sample procedure: The study is a single blind clinical trial in which 30 patients will be selected on the basis of simple randomized sampling procedure & will be divided into 2 equal groups.

Group A (Trial Group):

15 Patients will be given trial Drug (Churna of Usira, Goksura, Ghana, Samanga, Nagakesara and Padmaka) 4gms TID administered orally with Honey and water as anupana from 24 weeks to 36 weeks of pregnancy.

Group B (Control Group):

15 Patients will be given a placebo from 24 weeks to 36 weeks of pregnancy.

INCLUSIVE CRITERIA: -

1)Age 18 – 35 years of pregnant lady who are willing to take part in research work.

2)Pregnancy between 24 weeks up to 36 weeks.

3)H/O Preterm labor.

4)H/O Premature Contraction of Uterus.

EXCLUSIVE CRITERIA

  1. Patient with polyhydramnios.
  2. Patient with multiple gestations.
  3. Patient having any drug abuse (Smoking).
  4. Pregnancy with fibroid.
  5. Hemorrhage in pregnancy.
  6. Cervical incompetence.
  7. Fetal distress.
  8. Rupture of membranes.
  9. Chorio- amnionitis.
  10. Systemic diseases.

SUBJECTIVE PARAMETERS:

  1. Pain & Discomfort in abdomen.
  2. Stiffness of abdomen.
  3. Backache

OBJECTIVE PARAMETERS:

  1. Uterine Contraction (Time duration in seconds and frequency per day)
  2. USG – for Gestational age , fetal weight ,cervical length and Biophysical Profile (in Certain cases)

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 STUDY

Follow Up is done after every four weeks for three months. Patient is excluded from the study after 36 completed weeks.

7.3 INVESTIGATION REQUIRED

  1. C .B.C
  2. H.I.V.
  3. HBsAg
  4. VDRL
  5. Blood Group
  6. Urine -Routine & microscopic
  7. USG

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR

INSTITUTION:– Yes obtained.

LIST OF REFRENCES.

  1. John Bonner and William Dunlop, Recent advances in Obstetrics and Gynecology 23,Royal society of Medicine Press Ltd U.K. 2005 PP 15.
  2. Ian Donald’s Practical Obstetrics Problems Edited by Reenu Mishra , BI , Publications pvt Ltd . New Delhi , 6th Edition. PP 399.
  3. Vaid Shri Lakshmipati Shashtri, Yogratnakara, Chaukhamba Publication Varanasi, 2004 8th Edition PP 419.
  4. Pandit Harihar Prasad Tripathi , Harita Samhita, Chaukhamba Krishnadas academy, Varanasi, 2005 1st Edition PP 454.
  5. Prof K.R.Srikantha Murthy, Bhavaprakasa of Bhavamisra, Chowkhamba Krishnadas academy ,Varanasi Vol 2, 2005. IIIrd Edition P.P 789.
  6. Kavivar Shri Shaligramji Vaishya ,Shri Vaid Shankarlalji Jain Khemraj, Vangsen, Shri Krishnadas publication, Mumbai, 1996 eddition PP 838.
  7. Srivijayaraksita and Srikanthadatta, Sri Sudarsana Shastri, Madhav-nidanam of Sri madhavakara , Vol II, 31st PP 365.
  8. Shri Lalchandra Vaid, Astang Hrudya Matilal Banarasi puflication , Delhi, 1990, Reprint .77.
  9. Prof P.V.Tewari, Kasyapa – Samhita or Vrddhajivakiya Tantra, Chankhamba Vishvabharati ,Varanasi 2002 Reprint PP 136.
  10. Dr. Brahmananda Tripathi , Charak Samhita , Chaukhamba Surbharati Prakashan , Oriental Publishers and Distributors, Varanasi , Reprint 2005. PP 877.
  11. Kaviraja Ambikadutta shastri, Sushruta Samhita Chaukhambha Sankrit Sansthan Publishers and Distributors of Oriental Cultural Literature, Varanasi , Reprint 2007. PP 15.
  12. Dr. Gyanedra Pandey ,Dravyaguna Vijana chawkhambha Krishnadas Academy , Varanasi, VOI, II, III , Third Edition 2005 , Reprint 2004 . PP, 685, 382 636, 659, 1, 740.
  13. Dr. J.L.N. Shastry , Dravyaguna Vijana, Chawkhamba Orientalia , Varanasi , 2005 IInd Edition PP 67 , 988, 551, 558. 747.
  14. Gary Cunningham , William obstetrics International , Publication 21st Edition. PP 688.
  15. D. C. Dutta . Text Book of Obstetrics, New Central Book Agency Pvt LTD Calcutta ,2004, 6th Edition.PP 314.

9 SIGNATURE OF THE CANDIDATE :.

10. REMARKS OF THE GUIDE:

11.NAME & DESIGNATION OF

(In block letters)

11.1Guide :DR.SUSHMITA PRIYADARSHINEE OTTA,

M.S.(PTSR);U.U.)

ASST. PROF.

P.G.DEPT.Prasuti Tantra and Stree Roga

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

11.2 Signature:

11.3 Co-Guide :

11.4 Signature:

11.5 Head of Department: Prof. Dr. PRABHA SHARMA,

M.D. Ph.D(B.H.U.)

Professor and H.O.D.

P.G.DEPT. Prasooti Tantra

and Stree Roga

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

11.6 Signature :

  1. 12.1 Remarks of the Chairman &:

Principal

12.2 Signature:

1