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CTRI Number  CTRI/2024/04/065239 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 01/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Evaluating the efficacy of Pippalayadi Phanta (Kalpit Yoga) in alleviating pain and discomfort associated with Menstrual Periods(Kashtartava) 
Scientific Title of Study   A Clinical Study on Pippalayadi Phanta on Kashtartava (Primary Dysmenorrhea) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Pariyani 
Designation  Bams 3rd year UG Scholar 
Affiliation  Post Graduate Institute of Ayurved DSRRAU Jodhpur 
Address  PG Department of Prasuti Tantra and Stri Roga Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  7023414980  
Fax    
Email  dibschotu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Sharma 
Designation  Associate Professor PG Department of PTSR , PGIA , Jodhpur 
Affiliation  Post Graduate Institute of Ayurved DSRRAU Jodhpur 
Address  PG Department of Prasuti Tantra and Stri Roga Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9166607559  
Fax    
Email  vd_rashmi11@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rashmi Sharma 
Designation  Associate Professor PG Department of PTSR , PGIA , Jodhpur 
Affiliation  Post Graduate Institute of Ayurved DSRRAU Jodhpur 
Address  PG Department of Prasuti Tantra and Stri Roga Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad, Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9166607559  
Fax    
Email  vd_rashmi11@yahoo.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved DSRRAU Jodhpur 
Address  PG Department of Prasuti Tantra and Stri Roga Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad, Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India 
Type of Sponsor  Government medical college 
 
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 Rashmi Sharma  Post Graduate Institute of Ayurved DSRRAU Jodhpur   PG Department of Prasuti Tantra and Stri Roga, OPD Room number (5), Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad, Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN 		 9166607559

vd_rashmi11@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Post Graduate Institute of Ayurved  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Pippalayadi , Reference: NA, Route: Oral, Dosage Form: Phanta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: It is a new drug (kalpit yoga) not mentioned in classical texts. 5 grams of Yavkoot churn Pippalayadi phanta ( Pippali,Marich,Sunthi,Ajwain,Hingu) to be filled into disposable tea filter bags, should be dipped in 20 ml hot water for 5-7 minutes before consumption.
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1) Female patients coming with chief complaint of
Kastartava [Primary dysmenorrhea] with scanty
or average amount of menses (both married and
unmarried) for more than 2 consecutive cycles.

2) Female patients in the age group 14 to 35 years
of age.

3) Female patients with a history of using
analgesics.

 
 
ExclusionCriteria 
Details  1) Female patient with a history of any systemic
illness.

2) Female patients with menstrual irregularities.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the clinical study on Pippalayadi Phanta on Kashtartava (Primary Dysmenorrhea) is the reduction in pain intensity or severity of dysmenorrhea symptoms, assessed using the Walidd score and pain intensity grade scale. This assessment is conducted during the first 3 days of menses, followed by monitoring after 15 days. The same assessment format is repeated in the subsequent cycle.  7 days each month prior to expected date of menses (2 month consecutive cycle) 
 
Secondary Outcome  
Outcome  TimePoints 
1) If the use of herbal hot infusion results in significant reduction in pain intensity & improved quality of life, this natural remedy could offer a safe & accessible alternative to traditional medications to provide valuable insights into the use of herbal remedies for managing primary dysmenorrhea.

 		 14 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   11/04/2024 
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="0"
Days="14" 
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  
To assess the efficacy of  Pippalayadi Phanta on Kashtartava (Primary Dysmenorrhea) in alleviating pain and discomfort and improving the quality of life.

 
Study design single-arm open-label study. Duration of trial 14 days for 30 patients suffering from pain, discomfort (Primary Dysmenorrhea) and the scanty or average amount of menses during regular menstrual monthly cycle.                                                                                   
Route: oral              
Dosage: 20 ml bd  (7 days before the expected date of  menses)  
                        
Patients will be selected based on inclusion and exclusion criteria and assessed accordingly.

A Plain Empty Filter Paper Tea Bag sachet will be taken and filled with coarse powder of 5 drugs ( Pippali, Marich, Sunthi, Ajwein, Hingu)  which is to be dipped in 20 ml hot water for 5-7 mins and to be administered orally (Phanta Kalpana).

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