| CTRI Number |
CTRI/2024/05/066715 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study the effect of Chaturbeeja Churana Ghanvati in Primary Dysmenorrhea (Udavartini Yonivyapad) |
|
Scientific Title of Study
|
A Single Arm Clinical Study to Evaluate the Efficacy Of Chaturbeeja Churna Ghanvati in The Management of Primary Dysmenorrhea (Udavartini Yonivyapad ) |
| 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 Bharti |
| Designation |
PG Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune MAHARASHTRA 411018 India |
| Phone |
9873265057 |
| Fax |
|
| Email |
bharti.gahlawat1992@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pradnya Shirke |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune MAHARASHTRA 411018 India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pradnya Shirke |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
MAHARASHTRA 411018 India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurveda and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Bharti |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Bharti |
Dr D Y Patil College of Ayurveda and Research Centre |
OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Pune MAHARASHTRA |
09873265057
bharti.gahlawat1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. 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: Chaturbeeja Churana, Reference: Bhavprakash, Haritakyadi varga 6/88-89, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient’s suffering from Painful menstruation for more than 3 consecutive cycles.
2.Age groups between 12 to 25 years shall be selected (Inclusive of both Years) |
|
| ExclusionCriteria |
| Details |
1.Known case of Secondary dysmenorrhea.
2.Any pelvic pathology like Fibroid, Adenomyosis, Ovarian tumors, Endometriosis, Pelvic inflammatory disease.
3.Women diagnosed with congenital anomalies of reproductive tract, pelvic infections.
4.Other medical disorders which make patient at high risk- like Epilepsy, Anaemia Hb less than 9gm/dl, Heart disease, Diabetes.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Chaturbheeja Churna Ghanvati in the management of Dysmenorrohea on the bais of VAS Scale and WaLIDD Scale for Pain. |
7 days before menstrual cycle upto three days during menstrual cycle for 3 consecutive menstrual cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study other effects of Chaturbeeja Churna Ghanvati in Primary Dysmenorrhoea, If any. |
7 days before menstrual cycle upto three days during menstrual cycle for 3 consecutive menstrual cycles |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/05/2024 |
| Date of Study Completion (India) |
22/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/06/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Menstruation, conception & motherhood are the creative aspects of procreation. Among them, menstruation is one of the physiological process seen in reproductive phase, which denotes the healthy state of female reproductive system. Dysmenorrhea is the Greek terminology defined as painful menstruation of sufficient magnitude so as to incapacitate day to day activities. It may be categorized into two types:- 1)Primary Dysmenorrhea 2)Secondary dysmenorrhea . Primary dysmenorrhea is painful menses in women with normal pelvic anatomy usually begins during adolescence. It is characterized by crampy pelvic pain beginning shortly before or at the onset of menses and lasting 1-3days. The pain is of spasmodic in nature that usually confined to lower abdomen and may radiate to the back and legs. Systemic discomfort like nausea, vomiting, fatigue, giddiness, diarrhea, headache may be associated. In Ayurveda, primary dysmenorrhea can be correlated with Udavartini Yonivyapada which is characterized by painful menstruation. Udavartini is derived from Udavarta, that is upward direction of vayu. Charka first described Udavartini in Vataja nanatmaja diseases. He also elaborated the same in chikitsasthana. Rajas gets pushed in upward direction due to the pratiloma Gati of Apana Vayu because of obstruction in the normal flow in Pakwashaya,that is the chief site of Apana vayu itself. Menstrual pain of primary dysmenorrhea now become more prevalent because of the lifestyle and dietary habits. With a prevalence of more than 70% primary dysmenorrhea is becoming the most common gynecological problem impacting daily activities of women especially teenage girls. Today’s dietary habits and lifestyle also contribute to the increasing incidence of dysmenorrhea. Primary dysmenorrhea is not a real threat of life but can greatly affect ones quality of life. The Aim of study is to evaluate the efficacy of Chaturbeeja Churana Ghanvati in Primary Dysmenorrhea ( Udavartini Yonivyapad). Total 40 Patients will be enrolled and 1 gram of Chaturbeeja Churana Ghanvati will be given with dosage of 2 tablets of 250mg twice a day. the age group taken for the study will be from 12 years to 25 Years old Menstruating Women. |