FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082168 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study effectiveness of Ajmoda Churna in the management of painful menstruation in age group 18 to 35 years 
Scientific Title of Study   A randomized controlled clinical study to evaluate the efficacy of Ajmoda churna in the management of kashtartava in age group 18 to 35 years 
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 Sneha Chandrashekhar Waghmode 
Designation  PG Scholor 
Affiliation  PDEAs Of Ayurved And Research Center Nigdi Pune 
Address  Department of Stree Rog Prasutitantra PDEAs college Of Ayurved And Research Centre Sector 25 Nigdi Pune Maharashtra 411044 Pune MAHARASHTRA India

Pune
MAHARASHTRA
411044
India 
Phone  8888763600  
Fax    
Email  snehawaghmode97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinayak Shinde 
Designation  Professor 
Affiliation  PDEAs Of Ayurved And Research Center Nigdi Pune 
Address  Department of Stree Rog Prasutitantra PDEAs college Of Ayurved And Research Centre Sector 25 Nigdi Pune Maharashtra 411044 Pune MAHARASHTRA India

Pune
MAHARASHTRA
411044
India 
Phone  9850933512  
Fax    
Email  drvkshinde@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sneha Chandrashekhar Waghmode 
Designation  PG Scholor 
Affiliation  PDEAs Of Ayurved And Research Center Nigdi Pune 
Address  Department of Stree Rog Prasutitantra PDEAs college Of Ayurved And Research Centre Sector 25 Nigdi Pune Maharashtra 411044 Pune MAHARASHTRA India

Pune
MAHARASHTRA
411044
India 
Phone  8888763600  
Fax    
Email  snehawaghmode97@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Center Sector 25 Nigdi Pune 
 
Primary Sponsor  
Name  PDEAS College Of Ayurved and Research Center Nigadi Pradhikaran Pune 
Address  Department of Stree Rog Prasutitantra PDEAs college Of Ayurved And Research Centre Sector 25 Nigdi Pune Maharashtra 411044 
Type of Sponsor  Private 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 Sneha Chandrashekhar Waghmode  PDEA Ayurved Rugnalaya And Sterling Multispecialty Hospital  OPD No 119 Streerog and Prasutitantra Department Nigdi Pradhikaran Pune 411044 Maharashtra Pune MAHARASHTRA
Pune
MAHARASHTRA 
8888763600

snehawaghmode97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PDEAS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R398||Other symptoms and signs involvingthe genitourinary system. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1)Patients Complaining of Painful Menstruation for at least 2 Consecutive Cycles
2)Age group 18 to 35 years
3)Married Unmarried Patients having Regular Menstrual Cycle 
 
ExclusionCriteria 
Details  1) Irregular Periods
2) Heavy and Excessive Periods
3) Patient having Pelvic Pathology Endometriosis PID Tuboovarian mass Adenomyosis Cystitis
4) Patient with IUCD OC pills
5) Disease Related to Uro genital System
6) Patient having Uterine Pathology Uterine fibroid Endometriosis
7) Patient taking any hormonal Therapy
8) Patient taking NSAID 
 
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 
clinical study to evaluate the efficacy of
Shatpushpa Churna and Ajmoda Churna in the management of Kashtartava of follow
up wise result before and after treatment in the
management of Kashtartava with the help of
case record proforma and clinical examination
for 3 Months 
3 months treatment with 3 follow ups on 1st, 2nd,
3rd (4th or 5th Day) menstrual cycle 
 
Secondary Outcome  
Outcome  TimePoints 
To observe adverse effect if any  3 Months (1st, 2nd, 3rd consecutive menstual
cycles) 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   N/A 
Date of First Enrollment (India)   20/03/2025 
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="1"
Months="6"
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  
    Kashtartava is the symptom mention in various Yonivyapadas . Vata being the main causative factor for this condition as painful menstruation. It is commonly compaired with Dysmenorrhea of modern science and commonest of all gynecological complaints the menstrual blood flow is mainly under the control of Apana vayu vitiated Vata dosha the main causative factor of Kashtartava.
    All the four factor Rutu ( Fertile period ) Kshetra ( female genital organ or whole body),Ambu(ahar rasa),Beeja(sperm and ovum)are affected by the Kashtartava. the process of Rajpravartana is affected by age,occupation,social staus ,nutrition,the work place and mode of working ,heavy and stressed working schedules eg.factory workers, IT sectors ,professions needs to maintain high physique like armed forces,defence
   Women suffer from many disturbances naturally which commonly go unnoticed, among which menstrual pain stands most important. Every month majority of women experience various symptoms attributed to their menstrual cycle. Dysmenorrhea being the most common among them .
   Dysmenorrhea is defined as painful menstruation is one of sufficient magnitude so as to incapacitate day to day activities . it is usually primary and associated to normal ovulatory cycles and no pelvic pathology more than 50% of menstruating women, teenagers suffers from primary dysmenorrhea out of more than 15% suffer this pain for 1-3 days or starting first 1-2 days or may be atleast one day of menstrual cycle.
   Pain is body’s most important alarm symptom. It draws attention to the fact, that should be noticed and bring patient for consultation. Total absence of pain or having mild pain do not make patient that much conscious to visit hospital. However uncontrolled pain is the single most common reason for people seek medical advice.
   Conventional treatment of dysmenorrhea consist of Non-Steroidal Anti Inflammatory Drugs,hormonal therapy,which causes side effects. Ayurvedic herbo-mineral ,non hormonal ,nontoxic preparations are proved effective in dysmenorrhea.
   The drug Ajmoda churna mentioned in Dhanvantari Nighantu effective in the Management of Kashtartava.
 
Close