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CTRI Number  CTRI/2024/05/067380 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Novel Method to Standardize the Oral Thin Film Prepared from the Ayurveda Drugs for the patients of Oligospermia 
Scientific Title of Study   Oral Thin Film - A Novelty in the Ayurveda Practice (A Pilot Study) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sorathia Meet Suresh 
Designation  U.G. Student 
Affiliation  G. J. Patel Institute of Ayurveda Studies and Research 
Address  Department of Kayachikitsa, G.J.Patel Institute of Ayurvedic Studies and Research, New Vallabh Vidhyanagar, Anand, Gujarat 388120

Anand
GUJARAT
388120
India 
Phone  9687238006  
Fax    
Email  ssorathiameet@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Remesh Chandran 
Designation  Assistant Professor, Dept. of Kayachikitsa 
Affiliation  G. J. Patel Institute of Ayurveda Studies & Research 
Address  Dept. of Kayachikitsa, G. J. Patel Institute of Ayurveda Studies & Research, GIDC, ADIT Campus, New Vallabh Vidhyanagar, Anand, Gujarat 388345

Anand
GUJARAT
388345
India 
Phone  7012236368  
Fax    
Email  remeshchandran39@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Remesh Chandran 
Designation  Assistant Professor, Dept. of Kayachikitsa 
Affiliation  G. J. Patel Institute of Ayurveda Studies & Research 
Address  Dept. of Kayachikitsa, G. J. Patel Institute of Ayurveda Studies & Research, GIDC, ADIT Campus, New Vallabh Vidhyanagar, Anand, Gujarat 388345

Anand
GUJARAT
388345
India 
Phone  7012236368  
Fax    
Email  remeshchandran39@gmail.com  
 
Source of Monetary or Material Support  
G. J. Patel Institute of Ayurveda Studies and Research, Anand 
 
Primary Sponsor  
Name  Mr Meet Sorathia 
Address  Dept. of Kayachikitsa, G.J .Patel Institute of Ayurveda Studies and Research, New Vallabh Vidhyanagar, Anand - 388345, Gujarat. 
Type of Sponsor  Other [Self] 
 
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 
Dr Remesh Chandran  G. J. Patel Institute Of Ayurveda Studies And Research  Department of Kayachikitsa, GJPIASR, New Vallabh Vidhyanagar, Anand, Gujarat 388345
Anand
GUJARAT 
7012236368

remeshchandran39@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
G.J. Patel Institute of Ayurvedic Studies And Research & S.G. Patel Ayurveda Hospital & Maternity Home Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: OTF, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 150(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  25.00 Year(s)
Gender  Male 
Details  Patients of Age 21-45 Years, Primary or Secondary Infertility, Prediagnosed Case of Infertility 
 
ExclusionCriteria 
Details  Patient of Varicocele, STDs, Azoospermia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Oral Thin Film is effective in increasing the semen counts.  7 Days. 
 
Secondary Outcome  
Outcome  TimePoints 
The Oral Thin Film is effective in the Oligospermia.  7 Days 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Ayurveda, the science of life aims maintaining the health of the healthy individuals and curing the diseased ones. To fulfill this aim, there are eight parts of the Ayurveda known as Ashtanga Ayurveda. Ashtanga Ayurveda works at various aspects of the individual to promote health. Ayurveda described the treatment protocol either in the form of Antah Parimarjana Chikitsa or in the form of Bahir Parimarjana Chikisa. Antah Parimarjana Chikitsa (Internal therapeutics) incorporates the Sodhana Karma (Purification measures) i.e. Vamana, Virechana, Basti, Nasya, Dhoompana, Gandusha, Kavala etc. as well as the Shamana Karma (Pacification measures) by prescribing various medicines depending upon the condition of the disease.  While the Bahirparimarjana Chikitsa includes all the external therapeutics such as Lepa, Upnaha, Pariseka, Abhyanga, Pichu, Agnikarma etc. Therfore both the Bahir Parimarjana Chikitsa & Antah Parimarjana Chikitsa acts as the drug delivary system in the field of Ayurveda.

If we look at the Allopathy System of Medicine, we can find various routes of drug administration. Medications can be taken in a variety of ways – by swallowing, by inhalation, by absorption through the skin, or by injection. Each method has its own advantages and disadvantages. However improving current delivery methods or designing new ones can enhance the use of existing medications. Till date there is no development of the oral drug delivery system in the form of Oral Thin Films in the field of Ayurveda. The same intervention of designing new forms of drug administration to enhance the use of existing medications will play a significant role in the field of Ayurveda.

 Oral thin film is the most advanced and promising new approaches for drug delivery as it offers more flexibility and comfort. ASU drugs administered in the form of Oral Thin Film are the novel approach in oral drug delivery systems in the field of Ayurveda.

Today there are various routes for administration of the drugs, which includes sublingual route too. Every route has its own pros and cons. If we look at the pediatric as well as geriatric age group patients, it becomes difficult to administer drugs in the form of tablets, pills or parental route. Even in some patients we face difficulty in finding the venous vessels to administer the drugs though parental route. Though parental route is better compared to oral route as the drug can directly enter into the blood but the same may cause complications like thrombo-phlebitis, infection, damage to nerve or blood vessels etc. Therefore the drug administration in the form of Oral Thin Film sounds to be the better option in the pediatric as well as geriatric care. Hence this demands the new interventions in the field of the Ayurveda in the form of Oral Thin Film of the ASU drugs. We can analyze the efficacy and stability of the ASU drugs in the form of Oral Thin Film.

Therefore in this study, we are incorporating the proven Ayurveda drugs in the form of the Oral Thin Films for the qualitative and quantitative production of the Shukra Dhatu in males. It is an initial step of incorporation of Ayurveda drugs for the Vajikarana purpose. Interventions of Ayurveda in the Modern Drug Delivery System will have a wide scope in the future.


 
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