| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |