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CTRI Number  CTRI/2025/07/091842 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study to Evaluate the Efficacy of Nagarpipplyadi Yog in the management of Primary Dysmenorrhea  
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy Of Nagarpippalyadi Yog in the Management of 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  Dr Reena 
Designation  PhD Scholar 
Affiliation  Shree Guru Govind Tricentenary University Chandu Budhera Gurugram 
Address  Department of Prasuti Tantra evum Stree Roga Indian medical system Shree Guru Govind Tricentenary University Chandu Budhera Gurugram
Department of Prasuti Tantra evum Stree Roga Indian medical system Shree Guru Govind Tricentenary University Chandu Budhera Gurugram
Gurgaon
HARYANA
122505
India 
Phone  9740542440  
Fax    
Email  reenarohilla5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti Kumbar 
Designation  Professor & HOD 
Affiliation  Shree Guru Govind Tricentenary University Chandu Budhera Gurugram 
Address  Room no 005 D Block Dept of Prasooti Tantra evum stree roga Indian Medical System Shree Guru Govind Tricentenary University Chandu Budhera Gurugram

Gurgaon
HARYANA
122505
India 
Phone  9482628541  
Fax    
Email  drjyotik11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti Kumbar 
Designation  Professor & HOD 
Affiliation  Shree Guru Govind Tricentenary University Chandu Budhera Gurugram 
Address  Room no 005 D Block Dept of Prasooti Tantra evum stree roga Indian Medical System Shree Guru Govind Tricentenary University Chandu Budhera Gurugram

Gurgaon
HARYANA
122505
India 
Phone  9482628541  
Fax    
Email  drjyotik11@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr REENA 
Address  Department of Prasuti Tantra evum Stree Roga Indian medical system Shree Guru Govind Tricentenary University Chandu Budhera Gurugram Haryana 122505  
Type of Sponsor  Other [self sponsored] 
 
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 Jyoti Kumbar  Dr Jyoti Kumbar  Room no 005 D Block Dept of Prasooti Tantra evum stree roga Indian Medical System Shree Guru Govind Tricentenary University Chandu Budhera Gurugram Haryana pin 122505
Gurgaon
HARYANA 
09482628541

drjyotik11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee of faculty of indian medical system  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: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Nagarpipppalyadi Yog, Reference: Harita Samhita by Vd Jaymini Pandey Nirmala Hindi Commentery Tritiya Sthan 48 chapter page no 464 shloka 13 and 14 Chaukhamba Vishnu Bharti Publication 2010, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  patients having signs and symptoms of Kastaratava ex painful mensturation Nausea Vomitting Breast tenderness Headache and history of regular Menstrual cycle 
 
ExclusionCriteria 
Details  Irregular periods Trauma Patients Anatomical Anomaly Systemic Reproductive tract pathology 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain intensity VAS scale   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in overall quality of life  3 months 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   14/08/2025 
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="6"
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  

 All gynecological problems are outlined under the broad name Yonivyapada in Ayurvedic epics. Though the disease "Kashtartava" is not regarded as a distinct entity. In the literature it is a symptom of many Yonivyapadas particularly Udavarta  Vatala Sannipatika etc. Kashtartava is a condition that can be seen from 14 to 50 years old. Dysmenorrhea prevalence rates vary by age and region. It affects between 15.8 percent and 89.5 percent of menstruating women worldwide with 2 percent to 29.9 percent reporting severe pain. According to studies in India primary dysmenorrhea rates range from 50 percent to 87.8 percent. It is a Tridoshaja Vyadhi with Vata predominance in the female genital tract pathologically. This research study seeks to evaluate the efficacy of Nagarpippalyadi Yoga in managing Kashtartava primary dysmenorrhea offering a natural safe and effective alternative to conventional treatments. The study is significant in both validating traditional Ayurvedic formulations and providing a solution to a condition that affects millions of women globally. By contributing to the scientific validation of Ayurvedic therapies this research could have a lasting impact on integrative medicine and women’s health management. This justification emphasizes the importance relevance and potential benefits of conducting this clinical study while aligning the traditional wisdom of Ayurveda with modern scientific inquiry.


 
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