| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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.
|