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CTRI Number  CTRI/2025/08/093235 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 16/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Sukumara Gritha With And Without Hingvadi Churna In painful Mensuration. 
Scientific Title of Study   An Open Label Two Arm Clinical Study To Evaluatee The Effectiveness Of Sukumaraa Gritha With And Without Hingvadi Churna In Udavartini Yonivyapad (Primary Dysmenorrhoea)  
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 Kanak Jaiswal 
Designation  PG Scholar 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukkhabad UP  
Address  Department of Prasuti Tantra evum Stree Roga OPD NO-10, Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukkhabad UP
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad UP
Farrukhabad
UTTAR PRADESH
209602
India 
Phone  9675696328  
Fax    
Email  Kanak.jaiswal.97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramu G. 
Designation  Professor 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad UP  
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad UP
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP
Farrukhabad
UTTAR PRADESH
209602
India 
Phone  7652080752  
Fax    
Email  ayurlord@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kanak Jaiswal 
Designation  PG Scholar 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukkhabad UP  
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukkhabad UP
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad UP
Farrukhabad
UTTAR PRADESH
209625
India 
Phone  9675696328  
Fax    
Email  Kanak.jaiswal.97@gmail.com  
 
Source of Monetary or Material Support  
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad UP 
 
Primary Sponsor  
Name  Dr Kanak Jaiswal 
Address  OPD NP 10 Department of Prasuti Tantra Stree Roga Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP 209602 
Type of Sponsor  Other [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 Kanak Jaiswal  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital  Department of PG Studies in Prasuti Tantra evum Stree Roga OPD NO.10
Farrukhabad
UTTAR PRADESH 
9675696328

Kanak.jaiswal.97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Sukumara Ghrita, Reference: Sahastrayogam, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: warm water and milk), Additional Information: Empty stomach early morning
2Comparator ArmDrugClassical(1) Medicine Name: Hinguvadi Churna, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: with Sukumara Ghrita
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Patients between the age group 15 to 30 years
Patients full filling the diagnostic criteria
Pain during menstruation for at least previous 2 consecutive cycles
 
 
ExclusionCriteria 
Details  Known case of underlying pelvic pathology diagnosed by USG like Pelvic inflammatory disease fibroids endometriosis
Patients using Intrauterine contraceptives and contraceptive pills
Known case of Hypertension and Diabetes mellitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of Sukumara Ghrita in Udavartini Yoni Vyapad  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Sukumara Ghrita with Hingvadi Churna in Udavartini Yoni Vyapad  2 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/09/2025 
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="3"
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  

A key aspect of a woman’s overall well-being lies in the health of her reproductive system. Throughout a woman’s life, from puberty to menopause, the importance of maintaining a healthy yoni has been emphasized in both traditional Ayurvedic practices and modern medicine. However, with the modern lifestyle and dietary habits increasingly centered around fast and junk food, many women struggle to adhere to essential guidelines such as Dincharya, Rutucharya, Rajaswala, Rutumati, and Sutikaparicharya, which have been outlined by experts to promote women’s health. Ayurvedic texts also highlight specific women’s health issues, known as yonivyapad, with conditions such as Udavartini yonivyapad being among them.[1]

"Udavartini yonivyapad" is a term from Ayurveda that addresses gynaecological disorders related to the reproductive system. These disorders primarily affect the menstrual cycle and reproductive organs. They encompass a variety of conditions, including primary dysmenorrhea, which involves painful menstrual cramps without any underlying pelvic pathology. Many women experience primary dysmenorrhea during their reproductive years, and it can significantly impact their daily lives and well-being. Managing these conditions often requires a holistic approach that considers lifestyle factors, diet, herbal remedies, and sometimes personalized medical interventions.[2]

"Dysmenorrhea is a major challenge for many young women. Not only does it cause physical discomfort, but it also creates a lot of stress and worry for both the women experiencing it and their families. The symptoms include suprapubic cramps, lumbosacral backache, radiating pain down to anterior aspect of thigh and in severe cases, episodes of vomiting, diarrhoea, sync opal attack also will be there. While dysmenorrhea isn’t life-threatening, its effects on daily life are significant." The daily activities of women may be disrupted by menstrual pain, leading to absenteeism from work or school, and the inability to partake in sports or other activities. This can exacerbate the emotional distress caused by the pain. It is reported that not fewer than 50% of women experience some level of discomfort during menstruation, and 5-10% of girls in their late teens and early twenties are incapacitated for several days each month. The incidence of dysmenorrhea is influenced by social status, occupation, and age, resulting in different statistics for groups such as school girls, college students, factory workers, and women in the armed forces.[3]

 

Primary dysmenorrhea’s signs and symptoms are similar to those of Udavartni Yoniyapad, which is mentioned in classics. Vata is the primary dosha that causes Udavartni Yoniyapad. The drugs which are having Yoni shoolahara, vatahara, properties are selected for the management of Udavartini Yonivyapad with special reference to Primary Dysmenorrhoea  Hence this is an an attempt to find out safe and efficient treatment for Udavartini Yonivyapad  with Sukumara Gritha[4] with and without Hingvadi Churna [5]

Several studies were conducted on Udavartini Yonivyapad with different treatment modalities. These studies include oral medication and Panchakarma therapies including Uttarbasti, Anuvasanabasti, Matrabasti.

So here in this study we are using Sukumara Gritha with and without Hingvadi Churna.

 

 
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