RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
COMPLETED PROFORMA FOR THE REGISTRATION OF SUBJECT (BHAISHAJYA KALPANA) FOR THE DISSERTATION OF M.D. (AYURVEDA)
“A COMPARATIVE PHARMACEUTICO-CLINICAL EVALUATION OF BOLADI VATI AND KANYALOHADI VATI W.S.R. TO KASHTARTAVA”
By
Dr. AMBIKA PATIL B.A.M.S.
DEPT. OF P.G. STUDIES IN BHAISHAJYA KALPANA,
A. L. N. RAO MEMORIAL AYURVEDA MEDICAL COLLEGE
KOPPA, KARNATAKA.
Guide
DR. B. I. MATHAPATI M.D. (AYU)
PROFESSOR
DEPT. OF P.G. STUDIES IN BHAISHAJYA KALPANA,
A. L. N. RAO MEMORIAL AYURVEDA MEDICAL COLLEGE,
KOPPA, KARNATAKA.
A. L. N. RAO MEMORIAL AYURVEDA MEDICAL COLLEGE
KOPPA
2012-2013
From,
Dr. Ambika Patil,
M.D. (Ayu.) Scholar,
Dept. of P.G. Studies in Bhaishajya kalpana,
A.L.N. Rao Memorial Ayurveda Medical College,
Koppa, Karnataka
To,
The Registrar,
Rajiv Gandhi University of Health Sciences,
Karnataka, Bangalore.
Through Proper Channel
The Principal,
A.L.N. Rao Memorial Ayurveda Medical College,
Koppa, Karnataka.
Subject: Submission of Completed Proforma for Registration of for Dissertation.
Respected Sir,
I request you kindly to register the below mentioned subject against my name for submission of dissertation to Rajiv Gandhi University of Health Science Bangalore, Karnataka as partial fulfillment of M.D. (Ayu) Bhaishajya Kalpana.
Title of Dissertation
“A COMPARATIVE PHARMACEUTICO-CLINICAL EVALUATION OF BOLADI VATI AND KANYALOHADI VATI W.S.R. TO KASHTARTAVA”
Here with I am enclosing completed Proforma for registration.
Thanking you,
Yours Faithfully,
Place:
Date: Dr. Ambika Patil
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE, BANGALORE
KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. NAME OF THE CANDIDATE & ADDRESS : Dr. AMBIKA PATIL
W/O DR. CHANNABASAVANNA PATIL
OM SHANTI NILAYA, NAGAIDALAI
CHINCHOLLI (TQ), GULBARGA (D)
KARNATAKA - 585307
2. NAME OF THE INSTITUTION : A.L.N.RAO MEMORIAL AYURVEDIC
MEDICAL COLLEGE, HOSPITAL &
P.G. RESEARCH CENTRE,
KOPPA-577126
CHIKAMAGALUR (DT) KARNATAKA
3. COURSE OF STUDY AND SUBJECT : AYURVEDA VACHASPATHI
M.D.(AYU) SCHOLAR IN
BHAISHAJYA KALPANA
4. DATE OF ADMISSION OF COURSE : 11/10/2012
5. TITLE OF THE TOPIC :
“A COMPARATIVE PHARMACEUTICO-CLINICAL EVALUATION OF BOLADI VATI AND KANYALOHADI VATI W.S.R. TO KASHTARTAVA”
6. BRIEF RESUME OF THE INTENDED WORK
6.1 Need for the study
Women’s health is the primary factor to be considered for well being of family, society and culture. Any physical or mental disorder disturbs her educational, social and economic life1.
In our classics Vedana has been mentioned as two types, Sukhatmaka Dukhatmaka. Dukhatmaka vedana is referred to pain afflicting to both body & mind2. So Kashtartava is one among them, which makes to suffer a lot for women’s & adolescent girls.
Kashtartava is broad term which covers all the problems & ailments that a woman may suffer from pain during menstruation. It is a condition related with female reproductive system. By analysis one can state this is a result of Vatavruddhi, Apanavata margavarodha, Artava dushti Dhatukshaya. Kashtartava can be compared with the Dysmenorrhea in Modern medicine3.Its prevalence is estimated at 25% of women & up to 90% of adolescents. The majority of cases of Dysmenorrhea are Primary Dysmenorrhea. In the present study Kashtartava is taken for Primary Dysmenorrhea.
Today’s stressful modern life style, food habits are affecting more to the uterine environment which leads to higher incidence of Dysmenorrhoea. In this scenario Ayurvedic herbal preparations are proved safe & effective than modern therapeutics which may results in some unwanted complications.
As Boladi Vati & Kanyalohadi Vati are mentioned in the classical text of Rasashastra, their each individual drugs possesses the specific properties like Vatakaphahara, Shoolaghna, Vatanulomana, Dhatuposhaka etc, which helps to infer their effective treatment in Kashtartava .4 So A Comparative Pharmaceutico- Clinical Study of Boladi Vati & Kanyalohadi Vati is Undertaken to evaluate their Safety and Efficacy on Kashtartava.
6.2. Review of literature:
All the classical Ayurvedic texts will be reviewed for the study. Modern medicine books, journals and periodicals, which are related to the topics, will also be reviewed. For this, Review of literature is designed under 3 headings;
1. Drug review:
Drug review will be done from various classical texts for the present study. The trial drugs BOLADI VATI and KANYALOHADI VATI are selected from a classical text of Rasashastra.
Ø Ingredients of Boladi vati are4;
1. Bola - 4 karsha (1 karsha=12gms)
2. Trivrutta - 2 karsha
3. Hingu - 2 karsha
4. Tankana - 2 karsha
5. Ela - 2 karsha
6. Kaseesa bhasma - 2 karsha
7. Triphala - 2 karsha
8. Indravaruni mula - 2 karsha
9. Bhavanartha Jatamamsi khwatha - Q.S
Ø Ingredients of Kanyalohadi vati are4;
1. Ela - 200gms
2. Kaseesa bhasma - 200gms
3. Loha bhasma - 200gms
4. Varanga (twak) - 200gms
5. Shunti - 200gms
6. Bhavanartha kanyarasa - Q.S
2. Pharmaceutical Review:
The pharmaceutical process involved in the present study is:
a) Vati kalpana as per classical procedure5.
Various classical references will be reviewed for description of pharmaceutical process.
3. Disease review: Kashtartava is a symptom found in various Yoni Vyapats like Vatika, Udavarta & Paripluta etc., which will be studied in detail. The modern aspect of Dysmenorrhea will also be well studied. And other classical books of Rasashastra & Bhaishajya kalpana, previous works, journals related to disease will be reviewed.
6.3 Objectives of study:
1. To study the concept of Kashtartava.
2. To evaluate the action of Boladi vati on Kashtartava.
3. To assess the efficacy of Kanyalohadi vati in Kashtartava.
4. To evaluate & establish the comparative effect between 2 groups in Primary Dysmenorrhea.
5. To prepare the Boladi vati and Kanyalohadi vati as per classical reference.
6. To analyze Boladi vati and Kanyalohadi vati pharmaceutically, physico-chemically.
7.Materials & Methods
7.1 Source of data
This is being a pharmaceutical and clinical study, the source of data will be under 3 headings:
I. Pharmaceutical source:
By following the basic principles of vati kalpana as per the Ayurvedic pharmaceutical methods, preparation of Boladi vati and Kanyalohadi vati will be carried out in the pharmacy attached to A. L. N. Rao Memorial Ayurvedic Medical college, Koppa.
II. Analytical source: It includes;
· Physico-chemical:
1. Total ash
2. Acid insoluble ash
3. Water soluble ash
4. Loss on drying
· Qualitative Test:
a. Carbohydrate
b. Protein
c. Cardiac glycoside
d. Flavanoid
e. Tannin
f. Antraquione glycoside
g. Steroid
h. Triterpenoides
· Tablet tests:
1. Friability test
2. Disintegration test
3 .Hardness test
· Thin Layer Chromatography
· Quantitative estimation of iron
III .Clinical source:
Female patients diagnosed as having Kashtartava, from IPD & OPD at ALN Rao Memorial Ayurvedic Medical College & Hospital, Koppa & other associated Hospitals will be selected for the study. It is a randomized single blind clinical study with a pre-test & post-test design where in Boladi vati and Kanyalohadi vati are the trial drugs.
7.2 Methods of collection of data (Including sampling procedures if any)
Female Patients of the age group 15to30 yrs diagnosed as Primary Dysmenorrhea/Kashtartava based on clinical signs & symptoms are selected from In-patient & Out-patient department of ALN RAO MAMC & Hospital, Koppa & associated hospitals.
Sample Size:
It is a clinical study with pre-test & post-test design where 40 patients diagnosed as suffering from Kashtartava will be selected.
Groups: There will be two groups consisting of each 20 patients.
Duration of treatment:
The duration of treatment will be for 15days. Starting from 5 days before expected date of menstrual cycle & continued for10 days during menstruation for 2 menstrual cycles. Follow up for next menstrual cycle. A special format will be prepared with all points of history taking, physical examination etc as mentioned in our science & allied sciences.
Parameters:
Inclusion criteria:
· Patients within the age group 15 to 30 yrs
· Patients suffering from painful menstruation.
Exclusion criteria:
· If congenital anomalies is cause for Dysmenorrhea.
· Any pelvic pathology, acute infection
· Acyclic & excessive bleeding for more than 5days
· Endometriosis
· Adenomyosis
· Uterine fibroid
· Endometrial polyp
· PCOD& other medical, surgical Neurological conditions resulting in Dysmenorrhea& Patients of Known case of Diabetes mellitus & Hypertension.
Assessment criteria:
The patient’s response will be assessed on the basis of subjective parameters. Pain will be assessed by using clinical grading starting from 0(zero) to 3(three).
Scoring pattern of symptoms:
Grade 0 - Menstruation is not painful
Daily activities unaffected.
Grade 1 - Menstruation is painful (mild pain)
Daily activities unaffected
No analgesics needed.
Grade 2 - Menstruation is painful ( moderate pain)
Daily activities affected
Back ache, Analgesics needed.
Grade 3 - Menstruation is painful (Severe pain)
Unable to perform daily activities
Absent for work/classes
Severe Back ache
Analgesics show poor effect.
Associated symptoms:
· Atisara
· Vibhanda
· Praseka
· Chardi
· Bhrama
Final assessment of treatment:
Percentage of relief effects
· Cured- relief for 100%
· Marked improvement-relief from 75-100%
· Mild improvement –relief from 25-50%
· No relief – below 25%
Intervention:
Sl.no / Traits / Group A / Group B1. / Sample size / 20 / 20
2. / Medicine / Boladi vati / Kanyalohadi vati
3. / Dose / 500 mg BD / 500 mg BD
4. / Anupana / Lukewarm water / Lukewarm water
5. / Duration / 5 days before expected date& continued for 10 days for 2 months / 5 days before expected date& continued for 10 days for 2 months
6. / Follow up / Next menstrual cycle / Next menstrual cycle
7.3 Does the study require any investigation or intervention to be conducted on the patients or other humans or animals? If so please describe briefly:
Yes, the study will be conducted on Kashtartava patients only.
Investigations:
Haematological examination: Hb%,
RBS
TC
DC
ESR
Urine examination : Albumin, Sugar.
These investigations will be done to asses general conditions of the patients before and after treatment, if necessary.
7.4 Has ethical clearance obtained from your institution in case of 7.3?
Yes, ethical clearance has been obtained from the ethical committee formulated in the institution.
8. REFERENCES
1. Dew hurt’s text book of Obstetrics & Gynecology for Postgraduates, edited by D. Keith Edmonds, 6th edition, reprinted in 2000, 414 pp.
2. Acharya Agnivesha, Charaka Samhitha with introduction by Sri Satya Narayana Shastri, Varanasi, Chaukhambha Bharati Academy, 1998, Shareera sthana,1st chapter, Verse 133, 829 pp.
3. Prof.Premavati Tewari, Ayurvediya Prasuti tantra evam Striroga-2, Varanasi, Chaukhamba Orientalia, 2nd edition, 2000, 150 & 244 pp.
4. Atridev gupta’s, Bhaishaja samhita, Ahmedabad, Swasthya Mantralaya-Gujrat rajya, 1966, Gutika prakarana, Yoga number-23 & 76, 443 & 484 pp.
5.Acharya Sharangadhara, Sharangadhara Samhita, edited by Smt. Shailaja Srivastava, Varanasi, Chaukhamba Orientalia 2nd edition, 1998, Madhyama khanda, 7th chapter, Verse 1-3, 195 pp.
9. Signature of the Candidate :
10. Remarks of the Guide :
11. Name and Designation of (In Block Letters):
11.1) Guide : DR. B.I. MATHAPATI M.D. (AYU)
PROFESSOR
DEPT.OF RASA SHASTRA & BHAISHAJYA KALPANA
FACULTY OF POST GRADUATE STUDIES,
A.L.N.RAO MEMORIAL AYURVEDIC COLLEGE,
KOPPA-577126, CHICKMAGALUR-DT, KARNATAKA.
11.2) Signature :
11.3) Co-Guide : Dr. SANDEEP SARODE M.D. (AYU)
LECTURER,
DEPARTMENT OF POST GRADUATE
STUDIES IN BHAISHAJYA KALPANA
A.L.N RAO MEMORIAL AYURVEDIC
COLLEGE & PG RESEARCH CENTRE
KOPPA-577126, KARNATAKA.
11.4) Signature :
11.5) Co-Guide : DR. PRASHANT KUMAR JHA
C.I.P.R., D.I.M, P.G.D.E.E., M.Sc., Ph.D.
HEAD, QUALITY CONTROL LABORATORIES,
A.L.N.RAO MEMORIAL AYURVEDIC COLLEGE,
KOPPA-577126, CHICKMAGALURE-DT, KARNATAKA
11.6) Signature :
11.7) Head of the Department: DR. DINESH KUMAR MISHRA M.D. (AYU)
PROFESSOR & HOD
DEPT.OF RASA SHASTRA & BHAISHAJYA
KALPANA
FACULTY OF POST GRADUATE STUDIES,
A.L.N.RAO MEMORIAL AYURVEDIC COLLEGE,
KOPPA-577126, CHICKMAGALUR-DT, KARNATAKA
11.8 Signature :
12.
12.1 Remarks of Principal :
12.2 Signature :