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CTRI Number  CTRI/2015/07/006036 [Registered on: 20/07/2015] Trial Registered Retrospectively
Last Modified On: 24/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Ashvatha Phala Churna and Shveta Palandu Swarasa Bhavita Yavani in Ksheena Shukra(low sperm count)  
Scientific Title of Study   A Comparative study of Ashvatha Phala Churna and Shveta Palandu Swarasa Bhavita Yavani in the management of Ksheena Shukra w.s.r to Oligozoospermia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsakiya Jitendra Nathabhai 
Designation  MD Scholar 
Affiliation  IPGT And R A GAU Jamnagar 
Address  6 A Nilkanth Nagar Aradhana Street 2 Ranjit Sagar Road Jamnagar
Department of Kayachikitsa IPGT And R A GAU Jamnagar
Jamnagar
GUJARAT
361001
India 
Phone  09879158817  
Fax  02882676856  
Email  jeet12989@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mandip Goyal 
Designation  Assistant Professor  
Affiliation  IPGT And R A GAU Jamnagar 
Address  Department of Kayachikitsa IPGT And R A GAU Jamnagar
Department of Kayachikitsa IPGT And R A GAU Jamnagar
Jamnagar
GUJARAT
361001
India 
Phone  9427572306  
Fax  02882676856  
Email  kaurmandip22@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Varsakiya Jitendra Nathabhai 
Designation  MD Scholar 
Affiliation  IPGT And R A GAU Jamnagar 
Address  6 A Nilkanth Nagar Aradhana Street 2 Ranjit Sagar Road Jamnagar
Department of Kayachikitsa IPGT And R A GAU Jamnagar
Jamnagar
GUJARAT
361001
India 
Phone  09879158817  
Fax  02882676856  
Email  jeet12989@gmail.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Training and Research in Ayurved GAU Jamnagar 
 
Primary Sponsor  
Name  IPGT And R A GAU Jamnagar 
Address  Institute for Post Graduate Teaching and Research in Ayurveda jamnagar 361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Varsakiya Jitendrakumar Nathabhai  Institute for Post Graduate Training and Research in Ayurved  Department of Kayachikitsa Institute for Post Graduate Training and Research in Ayurved GAU Jamnagar GUJARAT
Jamnagar
GUJARAT 
9879158817
02882676856
jeet12989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Institute for Post Graduate Training and Research in Ayurved GAU Jamnagar 361008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from oligozoospermia ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A virechana with Ashvatha Phala churna  Dosage form powder Dose 3 gm twice a day Mode of Administration Oral Time of Administration Before food in Morning and Night Anupana a cup of warm milk with Sharkara Duration 60 days  
Comparator Agent  Group B Virechana with Shveta Palandu Swarasa Bhavita Yavani  Dosage form vati Dose 2 gm twice a day Mode of Administration Oral Time of Administration Before food in Morning and Night Anupana ghrita Duration 60 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1 Sperm count less than 15 million per ml according to WHO 2010
2 Patient with clinical presentation of Ksheenashukra Oligozoospermia i e Daurbalya Klaibya Shukra Avisarga Pandu etc
3 Patient Yogya for Virechana
 
 
ExclusionCriteria 
Details  1 Age below 20 and above 50 years
2 Sperm count more than 15 million per ml
3 Patient of azoospermia and aspermia
4 Patients of various diseases like varicocele accessory sex gland infection sexually transmitted diseases severe systemic diseases etc
5 Genetic disorders like Klinfelters syndrome
6 Taking treatment for major psychiatric problem
7 History of previous medications and trauma leading to oligozoospermia
8 Patient Ayogya for virechana
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The efficacy of the treatment will be assessed on the basis of improvement in the sperm count as well as subjective and objective criteria  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
achieving of fertility  60 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/12/2013 
Date of Study Completion (India) 12/01/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
not yet publish 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

1.      To evaluate and compare the clinical efficacy of  Ashvatha Phala Churna  and  Palandu Swarasa Bhavita Yavani Vati on Ksheena Shukra (Oligozoospermia).

Introduction

Among eight type of Shukra Dosha , Ksheena Shukra is caused due to vitiation of  Vata and Pitta and Daurbalya, Klaibya, Shukra Avisarga, Pandu etc. have been mentioned as its symptom. Ksheena Shukra, results due to Shukravaha Strotodushti, hence all factors which lead to Shukravaha Strotodushti play an important role in producing Ksheena Shukra. This include Shukradushtikara Ahara and Vihara like excessive intake of  Amla-lavana-katu-tikta-kashaya Rasa, exposure to Vata-Atapa, Shrama, Bhaya, Shoka ,Krodha etc, which can be considered as the primary cause of Ksheena Shukra. Intake of Madhura and Tikta Rasa food and proper Shodhana of the body at proper time are the major treatment for Ksheena Kshukra. 

AIMS & OBJECTIVES:

To evaluate and compare the clinical efficacy of  Ashvatha Phala Churna  and  Shveta Palandu Swarasa Bhavita Yavani Vati  after performing Virechana Karma on Ksheena Shukra (Oligozoospermia).

The thesis entitled “A Comparative  study of  Ashvatha Phala Churna and  Shveta Palandu Swarasa Bhavita Yavani  in the management of Ksheena Shukra w.s.r to Oligozoospermia” comprises of four parts viz. Conceptual study, Clinical study, Discussion, Summary and conclusion.

The total study was divided into conceptual contrive and clinical contrive.

 

Conceptual Contrive

The conceptual study has been presented under the heading of Disease and Drug review. In disease review, the details of historical aspects of Shukra and Kshina shukra have been mentioned. Then concept of Shukra which explains etymology, synonyms, definition of Shukra, Retas, Virya; origin and production of Shukra (spermatogenesis), characters and functions of Shukra (semen) has been discussed. This is followed by Nidana Panchaka of Kshinashukra such as various kinds of Nidana, Rupa, Samprapti and Chikitsa of Kshina shukra along with Pathyapathya have been dealt in length.

For the further understanding of pathophysiology review of oligozoospermia has been presented.

In Drug review, pharmcognostical, pharmaceutical and other details of the drug under trial viz. Ashvatha Phala Churna and Shveta Palandu Swarasa Bhavita Yavani Vati along with method of preparation of both drugs are in detail.

Drug review of the drugs used for Virechana Karma has also been discussed.

 

Clinical Contrive:

In the second chapter entilled clinical study embodies the methodology, selection of patients and method adopted for present clinical trial. It is followed by presentation of the results obtained in the clinical trial carried out on 38 patients of Kshina shukra along with its statistical analysis. The data obtained in the clinical study have been analysed and discussed in the detail in the third chapter under the caption of Discussion.

For the clinical study, 40 male patients complaining of symptoms of Ksheena Shukra or suffering from primary or secondary infertility more than one year and having sperm count less than 15 million/ml and willing to participate for the clinical trial were selected irrespective of religion, caste from the O.P.D of Kayachikitsa Department or referred from SRPT Department of I.P.G.T.& R.A. hospital, Jamnagar. Consent was taken from all subjects before including in the present study.

The selected patients were randomly divided into the following two groups, and managed for duration of two month addition to the time taken for Virechana Karma.

Patients were first subjected to Virechana, as per classics, for beginning 3 days 2gm of Trikatu powder with warm water was given thrice a day before meal. After achieving symptoms of Samyaka Deepana and Pachana Snehapana was done with Suddha Godhrita for 3-7 days in increasing dose depending upon Koshta and Agni of patient till Samyaka Snehapana Lakshana were achieved. This was followed by Sarvanga Abhyanga and Swedana for 3 days were patient was kept on normal diet. On the 4th day, Abhyanga and Swedana in the morning Virechana Yoga which consisited of Kwatha( Triphala + Trivritta) with Danti Churna was given. Average 8 hour and 8 minute were taken by the patients for Virechana and maximum patients (92.5%) reported Madhyama Shuddhi. After completion of Samsrjana Krama , there patients were randomly divided into two groups. After this patient of group A were given Ashwattha Phala Churna  3 gm twice a day orally daily in morning and evening before meal with a cup of warm milk with  Sharkara for the duration of  60th day, while in group B Shveta Palandu Swarasa Bhavita Yavani Vati was given in the dose of 4 Vati( 500mg each  )  twice a day orally morning and evening before meal with Anupana of 5ml of Godhrita for duration of  60th  day.

It is though that drugs which are administered after Shodhana provides better and quicker effect as Shodhana helps to enhance the bioavailability of drugs.

The observation found on the basis of generated data have been presented in brief which are as below:

40  male patients were studied in this series out of which maximum patients belonged to 21-30 years age group (52.5%), were to Hindu (92.5%);coming from urban area ( 67.5%), belonging lower middle class (47.5 %); with secondary level education (60%); factory laborers (27.5 %); and doing heavy physical work (67.5%). Maximum patients had Vishamagni (77.5%), Vata Pittaja Prakriti (52.5%), habit of  Vishamashana (87.5%) and taking Lavana Rasa dominant diet (60%). All the patients (100%) of this study were found with well developed secondary sexual character and having good relationship with their partner.

 

Maximum patients were found to be habituated to Tobacco (52.5%) and most of the patients wearing cotton undergarments (97.5 %), but tight underwear (67.5 %), and taking habit of warm water bath (67.5 %). Maximum number of patient complaint of disturbed sleep (62.5%) and 52.5 % of the patient had irregular bowel habit. Stress and worry (37.5%) was also reported in the patients.

Maximum number of patients were having Primary infertility (90%) with Moderate  oligozoospermic conditions (52.5%) with 1-3 years of chronicity (37.5%) Associated symptoms of Kshina Shukra reported by the patients were Shrama Maithuna (80%), Alpa Cheshta (75%), Daurbalya (67.5%), Alpa Shukra Pravritti (57.5%), Mukha Sosha (20%), Sadana (15%), and Bhrama (75%).

 

Analysis of generated data to find the effect of therapies on oligozoospermia showed that  in Group A ( Ashwattha Phala Churna)  38 patients were treated with Ashvatha Phala Churna 3gm twice a day with warm milk and Sharkara for 60 days after performing of Virechana Karma provided increase  in Sperm count of 59.78 %, 16.18% decrease  in Abnormal forms, and increase in  Semen volume by 36.81%.

 

In Group B (Shveta Palandu Swarasa Bhavita Yavani Vati  ); 38 patients were treated with 4 Vati twice a day with Goghrita for 60 days. Provided increase in sperm count (65%),  and abnormal form of sperm (20.74%).

On assessing the effect of therapies on associated symptoms it was found that

Ashvatha Phala Churna and Shveta Palandu Swarasa Bhavita Yavani Vati administered after Virechana Karma provided statistically highly significant improvement (p<0.0001) in Daurbalya, Sandhi Shula,Shrama, Maithune Ashakti,AlpaShukra Pravriti, as well as subjective criteria i.e. sexual desire, erectile function , erectile rigidity, ejaculatory function, orgasm, overall satisfaction, frequency of coitus, duration of coitus.

In addition in group B (Shveta Palandu Swarasa Bhavita Yavani Vati) provided 24.08% increase in the S.LH. In this group one patient was able to conceive his partner in the second month of treatment.

 

Overall effect of therapies which was assessed on the basis of changes in semen parameters as well as on subjective parameters. In Group A, (Ashvatha Phala Churna) given after Virechana Karma, 20% patients reported moderate improvement, 60% showed mild improvement and 20% patients remained unchanged. Whereas in Shveta Palandu Swarasa Bhavita Yavani Vati group 10% patients showed moderate improvement, 70 % showed mild improvement and remaining 20% were remained unchanged.

 


 
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