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CTRI Number  CTRI/2026/02/103382 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 08/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To study the additional benefit of Ayurvedic local therapies such as Yoni Kshalanam and Yoni Pichu along with oral Saptasaram Kashaya, helps to relieve pain during periods (congestive dysmenorrhea). 
Scientific Title of Study   A non-randomized comparative clinical trial on the add-on effect of yoni kshalanam and yoni pichu in congestive 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  Nandu Thankappan 
Designation  PG Scholar,Dept of Streeroga and Prasutitantra 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram 
Address  Government Ayurveda Medical College and Hospital,Pulimoodu junction, Thiruvananthapuram, Kerala Dept of Streeroga and Prasutitantra Room NO:1 Thiruvananthapuram KERALA 695001 India

Thiruvananthapuram
KERALA
695001
India 
Phone  8075344693  
Fax    
Email  drnandu1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Giby Thomas 
Designation  Associate Professor,Dept. of Streeroga and Prasutitantra,Govt. Ayurveda College Tripunithura 
Affiliation  Government Ayurveda College , Tripunithura  
Address  Dept.of Streeroga and Prasutitantra, Govt.Ayurveda College, Dhanwanthari Nagar Tripunithura, – 682301 Ernakulam District Kerala State

Ernakulam
KERALA
682301
India 
Phone  9446485655  
Fax    
Email  gibythomasdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nandu Thankappan 
Designation  PG Scholar,Dept of Streeroga and Prasutitantra 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram 
Address  Government Ayurveda Medical College and Hospital,Pulimoodu junction, Thiruvananthapuram, Kerala Dept of Streeroga and Prasutitantra Room NO:1 Thiruvananthapuram KERALA 695001 India

Thiruvananthapuram
KERALA
695001
India 
Phone  8075344693  
Fax    
Email  drnandu1999@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [SELF] 
 
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 Nandu Thankappan  Govt Ayurveda Hospital for women and children, Poojappura,Thiruvananthapuram  Dept of Streeroga and Prasutitantra, OP N0- 1 Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA 		 8075344693

drnandu1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Govt Ayurveda College,Thiruvananthapuram, Kerala, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N945||Secondary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yoni dhAvana, योनि धावन (Procedure Reference: charaka samhita, Procedure details: Yoni dhavana performed using freshly prepared Triphala-Nimba Kashaya as vaginal irrigation under aseptic precautions, once daily, starting from 10th day of menstruation for 7 days, for two consecutive menstrual cycles.)
(1) Medicine Name: Triphala Nimba kwatha, Reference: -, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 800(ml), Frequency: od, Duration: 7 Days
2Intervention ArmDrugClassical(1) Medicine Name: saptasaram kashayam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: guda), Additional Information: anupana-guda(3g)
3Intervention ArmProcedure-yoni picu, योनि पिचु (Procedure Reference: charaka samhita, Procedure details: Yoni pichu is performed using sterile cotton tampon soaked in Dhavakyadi Taila and placed intra-vaginally once daily, starting from the 10th day of menstruation for 7 days, for two consecutive menstrual cycles.)
(1) Medicine Name: Dhatakyadi Taila, Reference: Charaka samhita-yoniroga chikitsa, Route: Vaginal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days
4Comparator ArmDrugClassical(1) Medicine Name: Saptasaram Kashayam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: guda), Additional Information: anupana-guda(3g)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women aged 20 to 45 years with regular menstrual cycles (28 ± 7 days), diagnosed with congestive dysmenorrhea, and willing to participate in the study will be included. Participants should have a clinical and/or ultrasonographic diagnosis of congestive dysmenorrhea associated with one or more underlying pelvic pathologies, namely endometriosis, adenomyosis, uterine fibroids, chronic pelvic inflammatory disease, acquired retroversion of the uterus, or endometrial polyp. Only those fulfilling the above criteria will be enrolled in the study. 
 
ExclusionCriteria 
Details  Women with endometriotic cysts larger than five centimetres, malignancy, intrauterine contraceptive device in situ, elevated serum CA 125 levels above thirty five units per millilitre, pregnancy or lactation, or uncontrolled systemic illness will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Menstrual pain intensity – Assessed using the Visual Analogue Scale (VAS).  At baseline,4th week,8th week and 12th week(follow-up)
 
 
Secondary Outcome  
Outcome  TimePoints 
Vaginal pH – using standard pH strips  At baseline,8th week (after treatment period),12th week (followup)
 
 
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 4 
Date of First Enrollment (India)   02/03/2026 
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  

Dysmenorrhea is a common gynecological condition affecting women of reproductive age. Secondary dysmenorrhea or congestive dysmenorrhea is characterized by deep pelvic pain beginning before menstruation and is often associated with underlying pelvic pathology. In Ayurveda this condition can be correlated with Vatiki Yonivyapad caused by vitiation of Apana Vata. Recent evidence suggests a relationship between vaginal imbalance and menstrual pain, supporting the role of local vaginal therapies. This non randomized comparative clinical trial aims to evaluate the add on effect of Yoni Kshalanam and Yoni Pichu in congestive dysmenorrhea. The study will be conducted at the Department of Streeroga and Prasutitantra Government Ayurveda College Hospital for Women and Children Poojappura. Women aged twenty to forty five years diagnosed with congestive dysmenorrhea will be divided into two groups. The trial group will receive oral Saptasaram Kashaya along with Yoni Kshalanam and Yoni Pichu while the control group will receive oral Saptasaram Kashaya alone. Pain will be assessed using standard clinical assessment methods and the data will be statistically analyzed.

 
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