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CTRI Number  CTRI/2024/07/071567 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Gandhashma Parpati in treatment of Grahani roga. 
Scientific Title of Study   A Pharmaceutico-analytical and Exploratory study of Gandhashma parpati in management of Grahani roga 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yukta Singh Chauhan 
Designation  MD Scholar 
Affiliation  Post Graduate Institute of Ayurved, DSRRAU, Jodhpur 
Address  Dept of Rasa Shastra Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  8005547789  
Fax    
Email  yuktasinghchauhan29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajaram Agarwal 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Ayurved, DSRRAU, Jodhpur 
Address  Dept of Rasa Shastra Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9166934499  
Fax    
Email  drrajaramagarwal69@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yukta Singh Chauhan 
Designation  MD Scholar 
Affiliation  Post Graduate Institute of Ayurved, DSRRAU, Jodhpur 
Address  Dept of Rasa Shastra Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur


RAJASTHAN
342037
India 
Phone  8005547789  
Fax    
Email  yuktasinghchauhan29@gmail.com  
 
Source of Monetary or Material Support  
Dr. S R Rajasthan Ayurved University, Karwar, Nagaur road, Jodhpur 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved, Jodhpur, Rajasthan 
Address  PGIA, Dr S R Rajasthan Ayurved University, Jodhpur, Rajasthan, 342037 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Yukta Singh Chauhan  H.no. 176, C-block, sector - 5, Gandhinagar, Chittorgarh, Rajasthan 312001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yukta Singh Chauhan  Sanjeevani Hospital  Room No. 10 PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan 342037
Jodhpur
RAJASTHAN 		 8005547789

yuktasinghchauhan29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gandhashma Parpati, Reference: Rasa Kamdhenu, Route: Oral, Dosage Form: Parpati, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients aged between 18-40 years of either sex presenting with clinical features of Grahani roga
included in the study.  
 
ExclusionCriteria 
Details  Patients aged below 18 and above 40 years
Pregnant women and lactating mothers
Known cases of Intestinal tuberculosis, Ulcerative colitis, carcinoma, endocrine disorders, diabetes mellitus and cardiac disorders
Patient having major renal or liver disorders 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in subjective parameters  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life of patient  30 days 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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/ Phase 3 
Date of First Enrollment (India)   07/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

In the present era of fast-paced lifestyle, irregularity in meals, stressful work environment & sedentary lifestyle may lead to disturbances in digestive system. Treatment available in the present scenario for these bowel disorders is primarily symptomatic. Increasing or decreasing the intestinal motility, suppressing the disease gives temporary relief but doesn’t cure the ailment. Thus affecting the quality of life of the patient who keeps suffering. In comparison with traditional Rasa parpati5, preparation of Gandhashma parpati has procedures like quenching of Gandhak in different media & levigation of the Kajjali thus prepared.  Shodhan has great importance in ayurveda, so above mentioned procedures of quenching, levigation etc. must affect the efficacy of the aforementioned preparation. The enhancement of this medicine due to Kakmachi & Bhringraj’s effect on liver could be evaluated through analytical tests done in previous studies on Rasa Parpati. Thus this study will be conducted to assess the clinical efficacy of Gandhashma parpati in Grahani roga.

 
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