[ A ] VI. Brief resume of the intended work.
6.1 Need for the Study.
Sexuality has fascinated the people in all walks of life from ancient times to present. Healthy sexual functioning plays important role in maintaining the harmony and happiness in marital life. It is most essential thing to fulfill the procreational, recreational and relational aspects of life. It provides a media to express love, which is the base for all sort of creative activities. The absence of which hampers the marital relationship leaving to frustration, sometimes ends into divorce and causes inefficiency in performing the routine duties. The Male Sexual Dysfunction includes all sorts of disturbances of coital performance and sexual congress in male. Among the various phases of sexual response, the most essential is the achieving of normal erection with sufficient rigidity for penetrative intercourse, the absence of which ends into failure and dissatisfaction. This condition has been elaborately described as “Klaibya” in Ayurvedic classics and “Erectile Dysfunction” in modern texts.
The disease Klaibya is a multifactorial condition, mainly involving Bahu Doshavastha as a whole and Shukrakshaya specifically and Mana, Vata Dosha & Shukravaha Sroto Dushti. Owing to the feeling of inadequacy less commonly reported, a fear of impotence in all men above 40 years. Considering the grave nature of the disease though it does not reduces the life expectancy, it is selected for present study to find out better cure.
The word Impotency/ED is heard in many areas at present day living style as a serious problem. Because of it, the family life is disturbed and further leading to separation or divorce, ultimately causing distress with psychological disturbance, which may even lead suicidal attempts. On many occasions it is observed, stress and strain filled life in urban areas are the cause for such conditions to develop. In the National Health and Social Life Survey (NHSLS), which is a nationally representative sample of men and women age 18 to 59 year, 10% of men reported being unable to maintain an erection. Incidence was highest among men in the 50 to 59 age group (21%) and among men who were poor (14%), and less educated (13%).
Basti therapy as such is indicated in almost all diseases when adopted according to Bala, Dosha, Kala and Prakriti. It gives immediate relief and comfort. When Basti is administered after Shodhana, it bestows with Bala, Varna, Mardavata and Harshya. Basti augmented with Madhu and Ghrita is very effective in Vajikarana. It also enhances quality and quantity of Shukra & Mamsa.
Yapana basti and Anuvasana basti are of high significance for the one who is suffering and exhausted due to copulation, having pain in head region, bladder, thigh, penis, debility of the body. Out of 12 Yapna basti explained by Charaka, seven are acting on Shukravaha Srotas as Vrshya, Shukrala, Santanakara, Balya etc. These are said to act effectively on certain systemic disorders which are even closely related to Shukra and its function. These Yapana basti provides Vrshya, Bala-Varna janana, Buddhi-Medha, Agni, Apatya and Shukra. The most important thing is Yapana basti can be administered in all seasons. Even though it is considered as a type of Niruha, the hard & fast rule of the same are not applied in case of Yapana basti. Sneha Vrshya basti are also considered as Yapana basti, both are effective in the management of excessive sex induced problems, good for enriching Shukra, Mamsa and Bala. They can be successfully administered in males & females in case of Infertility. It is important to note that these Sneha basti and Yapana basti are both Niruha & Anuvasana or equilibrated basti, therefore very useful.
Yapana basti, Siddha basti, Madhutailika basti, Yuktaratha basti etc are grouped under Niruha not based on kwatha but depend on sneha and conducts of Niruha are also not applied here i.e. time, diet, retention period, post basti adaptation etc are very liberal,without any complications but very highly beneficial therapeutics.Hence considering all these preferential aspects, merits and scope of Yapana basti with special expectation as Vrshya, acting on both Shareerik & Manasik Vikriti by chiefly acting on Vata Dosha and all the srotasas and local shukravaha sroto mula, no strict conduct and any complication but efficacy of therapy in the advent of Vajikarana Therapy & Fertility benefits. The equilibrated vitality & vigor promoting modality, the Vrshya Yapana Basti prepared out of Laghu Panchamuladi and Kakolyadi with pro Vajikarana substance are selected for the present study. The complete regimen will be kept undisturbed to see the effect of Laghu Panchamuladi Vrshya Yapana basti and Kakolyadi Vrshya Yapana basti in the management of Klaibya/ED, a disorder due to Shukra dushti and disturbance of vata .
6.2. Review of Literature:
1. Explanation of Klaibya.1, 2, 3, 4
2. Explanation of Erectile Dysfunction. 5, 6
3. Explanation of Basti Karma.7
4. Explanation of Laghu Panchamuladi Vrshya Yapana Basti.8
5. Explanation of Kakolyadi Vrshya Yapana Basti.9
Previous Works done:
1. Mehra B.L. - Studiy on Klaibya (Male Sexual Dysfunction) & its management with Vajikarana, G.A.U. Jamanagar, 1996.
2. Bhatt Nilesh N.- Role of Manas in Klaibya (Male Sexual Dysfunction) & its management, G.A.U. Jamanagar,2000
3. Bhattad Santosh - A Comparative study of the role of the Vajikarana drugs administered Orally & by Basti in the management of Klaibya w.s.r. to E.D. , G.A.U. Jamanagar,2002
4. Rastogi K.C- A clinical study on the effect of Vanari Gutika in Klaibya, State Ayurvedic college, Lucknow-2003
5. Vajinath Sant Mangesh- Evaluation of the Narsimha Yoga in Klaibya w.s.r. to Erectile Dysfunction, DGM Ayurvedic College ,RGUHS, Banglore-2003
6. Saha Sundar- Study on Klaibya & its management with Svayamguptadi compound. Gopabandu Ayurveda Mahavidyalaya, Puri-2003
7. Aruna H.M. - A clinical study on Klaibya ( Male Sexual Dysfunction) w.s.r. to Uttar Basti. Ayurveda Mahavidyalaya, Hubli, RGUHS-2004
8. Nittekar Shivaprasad S. - Effect of Purnachandrodaya Rasa in the management of Klaibya, S.D.M. College of Ayurveda, Kuthpady, Udupi. RGUHS, Banglore-2005
6.3 Objectives of the Study:
1. To critically analyze Klaibya and Erectile Dysfunction in detail.
2. To assess the effect of Laghu Panchamuladi Vrshya Yapana Basti on Klaibya
3. To assess the effect of Kakolyadi Vrshya Yapana Basti on Klaibya
4. To assess the comparative effect of both these Basti on Klaibya.
[ B ] VII. Materials and Methods
The present study entitled “A CLINICAL MANAGEMENT OF KLAIBYA (ED) WITH LAGHU PANCHAMULADI AND KAKOLYADI VRSHYA YAPANA BASTI - A COMPARATIVE STUDY” is a comparative clinical trial which will be carried out with the following materials.
1. LAGHU PANCHAMULADI VRSHYA YAPAN BASTI.
2. KAKOLYADI VRSHYA YAPAN BASTI.
7.1 Source of Data:
In the present study the research scholar proposes to take the patients attending the O.P.D of Department of Post-Graduate studies in Panchakarma Ayurveda Mahavidyalaya Hospital, Hubli.
7.2 METHODS OF COLLECTION OF DATA
· A clinical survey of the patients attending the O.P.D and I.P.D of Department of Post-Graduate studies in Panchakarma Ayurveda Mahavidyalaya Hospital, Hubli will be made and patients fulfilling the criteria of diagnosis as per the Proforma will be selected for the study.
· A clinical evaluation of the patients will be done by collection of data through information obtained from history, physical examination and Laboratory Tests.
· Review of Literature will be collected from the library of Post Graduate Department of Panchakarma Ayurveda Mahavidyalaya, Hubli and from Authentic Research Journals, Websites and Digital Publications etc.
· The drugs required for the clinical study will be procured and prepared in the Department of Rasashastra and Bhaishajya Kalpana, Ayurveda Mahavidyalaya, Hubli.
Inclusion Criteria:
The subjects fulfilling following conditions will be selected
1. Subjects between the age group of 21 years to 50 years.
2. Subjects with normally developed genitals with proper secondary sexual characters.
3. Subjects diagnosed according to classical features of Klaibya ( Erectile Dysfunction)
4. Subjects who are fit for Basti Karma will be selected.
Exclusion Criteria:
1. Klaibya associated with any other Systemic Pathology.
2. Klaibya associated with disorders which interfere with course of treatment.
3. Klaibya associated with uncontrolled Metabolic and Endocrinal disorders including
Diabetes.
4. Subjects who are not fit for Basti Karma.
Diagnostic Criteria:
A special proforma incorporating all points of History taking and physical examinations mentioned in Ayurveda as well as Modern medicine will be prepared.
The Diagnosis will be made:
· On the basis of symptomatology of the disease in Ayurveda mainly Linga shaithilya, Mlana shishnatha, Shwasartha or Surat ashakta with or without other symptoms.
· On the basis of Trividha, Shadvidha,Ashtavidha and Dashavidha Pareeksha described by various Acharya.
· Supplemented with Modern symptomatological Parameters that is the International Index of Erectile functions (IIEF) viz., Erectile function, Intercourse Satisfaction, Orgasmic function, Sexual desire and overall satisfaction.
· To exclude pathological conditions as well as to assess the condition of the Subjects routine Hematological, Biochemical and Urine Examinations will also be carried out.
Parameters of Study:
Subjective Parameters:
· Linga shaithilya
· Mlana shishnata
· Shwasartha
· Surat Ashakta
Objective Parameters:
· Sexual health scoring pattern in males as per the IIEF which includes Erection, Sexual Desire, Rigidity, Ejaculation & Orgasm.
· Semen Analysis
Study Design: A Comparative Clinical Study.
Sample size: A Minimum of 30 Subjects diagnosed as Klaibya ( Erectile Dysfunction)
will be selected incidentally and randomly categorized into two groups
consisting 15 subjects in each group.
Group – A: Laghu Panchamuladi Vrshya Yapana Basti in Karma Basti schedule.
Duration: 30 Days
Follow up: 60 days
Group – B: Kakolyadi Vrshya Yapana Basti in Karma Basti schedule.
Duration: 30 days
Follow up: 60 days
Assessment Criteria : The data which are obtained by the clinical trial will be statistically analyzed by applying the student ‘t’ test.
The result will be recorded as,
§ Marked relief - Above 75% improvement
§ Moderate relief - 50%-75% improvement
§ Mild relief - 25%-50% improvement
§ No relief - Below 25% improvement
Observations:
Observational study includes Ayoga, Atiyoga, Samyak Yoga laxanas of basti. Its effect on different Seminal Parameters, Histological Parameters and Biochemical Parameters. Dosha dushti, Dhatu dushti, Sroto dushti laxanas. Physio-Chemical analysis of both Yapana Basti will be made.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly
YES
Investigations
1. BLOOD -
H B%
R B S
HIV
HBsAg
Lipid Profile
2. Urine:
Urine Routine
3. Semen Analysis
4. Hormonal Assay (if necessary)
Interventions:
Group – A:
· Amapachana: Haritakyadi Yoga with Ushnodaka, before food, for 3-5 Days (5-10 gm, 2 times a day)
· Sthanik Abhyanga: With Mahamasha Taila.
· Avagaha Sweda with Ushnodaka : 10-15 minutes.
· Yapana Basti: With Laghu Panchamuladi Vrshya Yapana Basti.
· Duration: 30 days (Karma Basti Schedule)
· Parihara Kala: 60 days
Group – B:
· Amapachana: Haritakyadi Yoga with Ushnodaka, before food, for 3-5
Days (5-10gm, 2 times a day)
· Sthanik Abhyanga: With Mahamasha Taila.
· Avagaha Sweda with Ushnodaka: 10-15 minutes
· Yapana Basti: With Kakolyadi Vrshya Yapan Basthi
· Duration: 30 days (Karma Basti schedule)
· Parihara Kala: 60 days
7.4 Has Ethical Clearance has been obtained from the institution in case of 7.3
YES
Ethical clearance has been obtained by the ethical committee constituted by Ayurveda Mahavidyalaya Hubli and written consent will be taken from each individual patient or by an attendant if the patient is illiterate on a printed consent form.
[ C ] VIII. List of References:
1. Agnivesha, Charaka Samhita, Edited and translated by Prof.P.V.Sharma, Published by Chaukhambha Orientalia, Vol.II, Page No 517-521.
2. Sushruta, Sushruta samhita with Nibandha sangraha commentary of Dalhanacharya edited by Narayana Ramacharaya Kavyateertha, Published by Krishnadas academy, Varanasi, Page No 597.
3. Yogaratanakara with Vidyaprabha Hindi Commentary by Dr.Indra Dev Tripathi and Dr. Daya Shankar Tripathi, published by Krishnadas Academy, Varanasi, Page No 874,1998.
4. Bhaishajya Ratnawali of Sri Govinda Dasji edited and enlarged by Bisagratna Shri Brahmashankara Mishra and translated by Dr. Kanjiv Lochan, Published by Chaukhamba Sanskrit Bhawan, Varanasi , Vol III Page No- 636-638.
5. A.P.I. Text Book of Medicine, 8th Edition, Chief editor- Siddhartha Shah, Published by The Association of Physicians of India, Mumbai, Vol II, Page No- 1351, 1381.
6. Davidson Principal and practice of medicine, 20th Edition edited by Nicholas.A.Boon, Nicki. R.colledge, Brian R Walker published by Churchill Living Stone, Page no 476-477.
7. Agnivesha, Charaka Samhita, Edited and translated by Prof.P.V.Sharma, Published by Chaukhambha Orientalia, Vol.II, Page No- 605-613, 658-659.
8. Agnivesha, Charaka Samhita, Edited and translated by Prof. P.V. Sharma, Published by Chaukhambha Orientalia, Vol.II,Page No-672
9. Agnivesha, Charaka Samhita, Edited and translated by Prof.P.V.Sharma, Published by Chaukhambha Orientalia, Vol.II,Page No- 660