This document provides information about a clinical study on "Rajonivriti Kalaj Lakshan" and its management with indigenous drugs Shatavari, Guduchi, and Yastimadhu. The study aims to evaluate the efficacy of these three Ayurvedic herbs in treating symptoms caused by menopause such as vasomotor, psychological, and gastrointestinal issues. It will be conducted on menopausal women between 40-60 years of age over a period of 3 months. Outcome measures will assess reduction of symptoms and improvement in quality of life.
This document provides information about a clinical study on "Rajonivriti Kalaj Lakshan" and its management with indigenous drugs Shatavari, Guduchi, and Yastimadhu. The study aims to evaluate the efficacy of these three Ayurvedic herbs in treating symptoms caused by menopause such as vasomotor, psychological, and gastrointestinal issues. It will be conducted on menopausal women between 40-60 years of age over a period of 3 months. Outcome measures will assess reduction of symptoms and improvement in quality of life.
This document provides information about a clinical study on "Rajonivriti Kalaj Lakshan" and its management with indigenous drugs Shatavari, Guduchi, and Yastimadhu. The study aims to evaluate the efficacy of these three Ayurvedic herbs in treating symptoms caused by menopause such as vasomotor, psychological, and gastrointestinal issues. It will be conducted on menopausal women between 40-60 years of age over a period of 3 months. Outcome measures will assess reduction of symptoms and improvement in quality of life.
A CLINICAL STUDY ON RAJONIVRITI KALAJ LAKSHAN AND ITS MANAGEMENT WITH INDIGENOUS DRUGS SHATAVARI, GUDUCHI AND YASTIMADHU.
TITLE SUBMITTED FOR THE DEGREE OF AYURVED DHANVANTARI (M.S. AYU) IN PRASUTI TANTRA AND STRI ROG UNDER
CHHATRAPATI SHAHU JI MAHARAJ UNIVERSITY KANPUR (U.P.)
SUBMITTED BY: DR. VASUNDHRA CHAUDHARY B.A.M.S. M.S. (SCHOLAR) S.A.M.C., ALIGARH GUIDE DR. RANI GUPTA M.S. (AYURVEDA) READER, PRASUTI TANTRA EVAM STRI ROGA S.S.A.M.C. & HOSPITAL, ALIGARH
POST GRADUATE DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA SRI SAI AYURVEDIC MEDICAL COLLEGE & HOSPITAL ALIGARH- 202001, U.P.
SESSION 2010-11 2
From Dr. Vasundhra Chaudhary B.A.M.S I Year M.S. (Ayu) Department of post graduate studies in prasuti tantra evam stri rog Sri sai ayurvedic medical P.G. college and hospital Aligarh 202001
To, The Registar, Chatrapati Sahuji Maharaj University Kanpur, Uttar Pradesh.
Through: The Principal and Head of department in Prasuti Tantra evam Stri Rog Sri Sai Ayurvedic Medical P.G. College And Hospital ALIGARH 202001
Respected Sir/Madam,
Subject: Submission of complete Performa for registration of subject for dissertation.
I request you to register the below mentioned subject in my name for the registration of subject for dissertation to the Chatrapati Sahuji Maharaj University Kanpur for partial fulfillment of M.S [ Ay].
Title of the Dissertation:
A CLINICAL STUDY ON RAJONIVRITI KALAJ LAKSHAN AND ITS MANAGEMENT WITH INDIGENOUS DRUGS SHATAVARI ,GUDUCHI AND YASTIMADHU.
Herewith I am enclosing completed Performa for registration of subject dissertation.
Thanking You Yours faithful Place : ALIGARH Dr. Vasundhra Chaudhary Date :
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ANNEXURE - 11
Completed preformed for registration of subject for dissertation
1. Name of the Candidate : Dr. VASUNDHRA CHAUDHARY and address I YEAR M.S. POST GRADUATE STUDIES IN PRASUTI TANTRA EVAM STRI ROG S.S.A.M.C. H ALIGARH
2. Name of Institution : SRI SAI AYURVEDIC MEDICAL P.G. COLLEGE ALIGARH
3. Course of study : M.S. IN PRASUTI TANTRA EVAM STRI ROG
4. Title of Topic : A CLINICAL STUDY ON RAJONIVRITI KALAJ LAKSHAN AND ITS MANAGEMENT WITH INDIGENOUS DRUGS SHATAVARI , GUDUCHI AND YASTIMADHU.
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5. BRIEF RESUME OF INTENDED WORK
5.1. Need for the study
Problems of different age group of women are still present and the most suffering age group is forty-plus due to change in reproductive life by permanent cessation of menstruation causing untoward physical and mental agonies called as menopause. Every woman faces varies physiological and psychological changes during this "change of life" as a part of hormonal derangement. Sometimes such disturbances attain the stage of disease or syndrome called as "Menopausal Syndrome" which is accompanied by various vasomotor, psychological, genital, locomotors and GIT related symptoms.
Normally, menopause occurs at a median age of 51 years, so a woman spends up to one third of her life in menopause About 75% of women are having uncomfortable physical symptoms and 50% experience psychological manifestations during menopause. About 50-60% of women seek medical help for that. Though menopause is a natural event as a part of the normal process of aging, it is turning into a major health problem in recent years in developed as well as developing countries like India.Being an alarming problem, it needs an effective and safe treatment.
In modern science, Hormone Replacement Therapy (HRT) is one and only alternative for this health hazard by which one can get spectacular achievement in combating the disease, but it has a wider range of secondary health complications like vaginal bleeding, breast cancer, endometrical cancer, gallbladder diseases etc. On the other hand, this therapy is not much effective in the psychological manifestations of this stage. They manage them by the long term use of Sedative, Hypnotics and Anxiolytic drugs, which may lead to various side effects like drowsiness, impaired motor functions, loss of memory, allergic reactions, non social behaviors, drug dependence etc.
Therefore, there is a wide scope of research to find out safe, potent, cost effective remedy from Ayurveda for the management of rajonivritijanya lakshana. From the previous works, it is well proved that this health hazard can be well managed with certain Ayurvedic therapeutics having Medhya and Rasayana properties. so, considering this view, some known rasayana drugs like shatavari, Yastimadhu, Guduchi (A.H. Ut. 39/60-61 ) is taken for present work in an attempt to search effective remedy for rajonivriti kalaj lakshana.
Rasayanam cha tajgeyam yajjara vyadhi nashanam. Sharangdhar
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5.2 References 1. Sushruta samhita with Ayurveda Tatvasandipika Commentary, edited by kaviraj dr. Ambika Dutta Shastri. 2. Astang Hridyam Nirmala Hindi Vyakhya by Dr. Brahmananda Tripathi 3. Ayurvediya Prasuti Tantra evam Stri Rog Part I by Prof Premvati Tivari. 4. Bhavaprakasha - Jayakrishnadas Haridas Gupta Kashi Sanskrit Granthmala. 5. Charaka Samhita - Ayurved Dipika Commentary of Chakrapanidatta, Edited by Vaidya Jadavaji Trikamji Acharya; Chaukhamba Surbharti Prakashan, Varanasi. 6. Dravyaguna Vignana by Dr. Gyanendra Pandey, Chaukhamba Prakashan, Varanasi. 7. Text book of Gynaecology by C. S. Dawn, 9th Edition, Calcutta. 8. Text book of Gynaecology by D. C. Dutta, Third Edition 9. Howkins and Bourne Shaws Text book of Gynecology 14 th edition .
5.3 PREVIOUS WORKS :
AT JAMNAGAR :
1. In 1993-95; A clinical study on Rajonivritti with special reference to menopausal syndrome by Dr. Kirtidevi 2. In 1996-98; A clinical study on the management of climacteric stage in women with special reference to menopausal syndrome by using certain Ayurvedic formulations by Dr. Kirtidevi Gohil (Ph. D. Thesis). 3. In 1998-2000, Comparative study between Rasayankalpavati & Shankhpushpi Vati in clinical study on Rajonivritti by Dr. Ajay Sood. 4. In 2000-2002, A comparative Pharmaco-clinical study of Rasayankalpvati and masyadivati on rajonivritti avastha janya Lakshana (Menopausal Syndrome) by Dr. Ami P. Modi. 5. In 2000-2002; A clinical study on Manas bhavas in Menopausal syndrome and its management by Medhya Rasayana Vati & Shirodhara by Dr. Manju Pateria.
At B.H.U :
1. In 1999, Effect of Vacha, Ashwagandha, Ulatakambala & Jatamansi on manopausal syndrome by Dr. Shipra Dhar.
5.4 OBJECTIVES OF THE STUDY
A literary work on rajonivriti janya lakshana in both ayurveda and modern literature. To evaluate the efficacy of indigenous use of shatavari, guduchi and yastimadhu in management of rajonivriti janya lakshan.
6.1 MATERIALS AND METHODS:
The patients: The patients attending the O.P.D. & I.P.D. of the S.S.A.M.C.H Aligarh will be registered for the present study.
The drugs : The test drug 'chalk churna' with placebo capsules and the standard drug "guduchi,shatavariand yastimadhu churna" will be prepared in Pharmacy of S.S.A.M.C.H Aligarh 6
6.2 PLAN OF STUDY:
Criteria of Selection
Patients willing to participate in the study and who agreed to give the written consent. Women aged between 40 - 55 years, having cardinal symptom i.e. cessation of Menstruation will be selected. Women having clinical features of Menopausal syndrome along with psychological disturbances will be selected.
Criteria of Exclusion:
Patients not willing to participate in the study Crippling conditions like malignancy etc. The cases of primary amenorrhea and other complicated cases. Menopausal women with untoward effects of HRT will be excluded from the present study.
Criteria of Assessment:
Subjective Criteria:
Results of the treatment will be assessed on the basis of relief in the sings and symptoms of the menopausal syndrome assessed before and after the treatment. Sign and symptoms to be assessed are Hot Flushes, Excessive sweating,Fatigue,Palpitation,Pain in joints, Backache, Loss of appetite, Flatulence, Constipation, Loss of urinary control ,Dryness of vagina, Headache, Irritability, Mood swing, Depression, Sleep disturbances, Loss of confidence, Forgetfulness, Decrease Libido.
Objective Criteria:
Routine hematological, urine and stool investigations.
Sample Size:
Total number of patients taken for study will be 30 excluding dropouts. The patients selected for study will be divided into 2 groups Group A and Group B consisting of 15 patients each.
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6.3 Drug dose and duration of treatment
Group A
Drug: Churna of shatavari ,yastimadhu and guduchi. Dose: 3 gms twice a day Route: Oral Anupana :Go Cheer (A.H.Ut 39/44), (A. H. Su 5/21) Duration: Three month.
Group B
Drug: Chalk churna capsules Dose: 1 capsules twice a day Route: Oral Anupana : Sterile water Duration: Three month.
Assessment will be done every 30 days interval after administration of the treatment.
6.4 Layout of Design :
Control Group A
Group A Treatment 1(T 1 ) 15 cases will be treated with trial drug.
Group B Treatment 2(T 2 ) 15 cases will be treated with placebo.
Design - 1
B.T T 1 /V S
A.T - Effectiveness of T 1 will be assesed
B.T T 2 /V S
A.T - Effectiveness of T 2 will be assesed
Design - 2
Effectiveness of T 1 will be assessed with T 2 .
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7. Signature of Candidate :
8. Remarks of Guide :
9. Name and designation of :
9.1 Guide Dr Rani Gupta Reader Department of post graduates study In Prasuti Tantra evam Stri Rog S.S.A.M.C.H Aligarh
9.2 Signature
9.3 Head of the Department : Dr Balen Vaishaiya Professor Department of post graduates study in Prasuti Tantra evam Stri Rog S.S.A.M.C.H Aligarh
An Open Explanatory Clinical Trial With A Pre-Test and Post-Test Design Evaluating The Combined Therapeutic Effect of Shashilekha Vati and Gomutra Ghan Vati in Shwitra