| CTRI Number |
CTRI/2025/03/082011 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate The Shulaghna Effect Of Hingvadi Churna In Udavartini Yonivyapad |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial To Evaluate The Shulaghna Effect Of Hingvadi Churna In The Management Of
Udavartini Yonivyapad With Special Reference To Primary Dysmenorrhia |
| 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 Nikita Raju Bisen |
| Designation |
MS Scholar Streerog and Prasutitantra |
| Affiliation |
R A Podar Ayurvedic Medical College Worli Mumbai |
| Address |
Dept Of Streerog And Prasutitantra R A Podar Ayurvedic Medical College Worli
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
8208438454 |
| Fax |
|
| Email |
nikitabisen1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRutuja Gaikwad |
| Designation |
Assistant professor |
| Affiliation |
R A Podar Ayurvedic Medical College Worli Mumbai |
| Address |
Dept Of Streerog And Prasutitantra R A Podar Ayurvedic Medical College Worli
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
9699825626 |
| Fax |
|
| Email |
drrutujasg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRutuja Gaikwad |
| Designation |
Assistant professor |
| Affiliation |
R A Podar Ayurvedic Medical College Worli Mumbai |
| Address |
Dept Of Streerog And Prasutitantra R A Podar Ayurvedic Medical College Worli
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
9699825626 |
| Fax |
|
| Email |
drrutujasg@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 8 M.A.Podar Hospital Worli Mumbai 400018 Maharashtra India
|
|
|
Primary Sponsor
|
| Name |
Dr Nikita Raju Bisen |
| Address |
Dept Of Streerog And Prasutitantra R A Podar Ayurvedic Medical College Worli Mumbai 400018 Maharashtra India |
| 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 Nikita Raju Bisen |
M A Podar Hospital Worli Mumbai |
Department of Gynaecology and Obstetrics first floor Podar Hospital Worli Mumbai 400018
Mumbai MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
8208438454
nikitabisen1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC R A Podar medical College Worli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hingvadi churna, Reference: Bhaishajyaratnavali of shri Govind dasji volume 2, edited by bhisagratna shri bramhashankar Mishra, commentary by shri kaviraja ambikadatta shastri,chaukhamba Sanskrit sansthan, Varanasi,edition:reprint ,2009., Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yavani churna, Reference: Narendra Kumar Meena,Ram Veer Sharma,management of spasmodic (Udavartini Yonivyapada) with Chaturbeeja Churna and Yogic Practices.AYUSHDHARA,2017;4(5):1363-1372., Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Patient fulfilling diagnostic criteria patients complaining of pain
during menses with other symptoms of Udavartini Yonivyapada for
at least three consecutive cycles
Patients with age group of 16 to 30 years old.
Married and unmarried patients
Patient with scanty or average flow |
|
| ExclusionCriteria |
| Details |
Patient having irregular menstruation.
Patient having congestive, poly or epi menorrhea
Patient having anatomical and congenital anomalies in genital tract.
Patient with Fibroid, cyst, endometriosis.
Patient suffering from any systemic disease like HTN, DM,
bleeding disorder, cardiac disease, APH, PIH.
Presence of HIV,HbsAg,VDRL,HPV Positive in the patient.
Patient using any IUCDs.
Patient having an endocrinological disorder like Hypothyroidism Hyperthyroidism |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significantly reduction in pain during menses |
2 Consecutive menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significantly reduction in pain during menses by using Higvadi churna than Yavani churna |
2 Consecutive menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
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)
|
: Primary objectives- To study the shulaghna effect of Hingvadi Churna in the management of Udavartini Yonivyapad with special reference to primary dysmenorrhea. -To find whether Hingvadi churna is more effective than Yavani churna in Udavartini Yonivyapad Secondary objectives- To study the effect of Hingvadi Churna on- Artava praman(menstrual flow) Praseka(nausea) Pain in other region-kati,vankshan,adhoudar shool Aruchi(loss of appetite) Group A - Hingvadi churna Group B - Yavani churna Appropriate Sampling Technique: Simple randomised sampling method by computerised random technique will be done for 76 female patients of age group 18 to 70 years. The subjects will be randomised in two study groups i.e., Group A and B. The time and date of recruitment shall also be recorded in the enrolment log Follow up: on 5 th day of menstrual cycle Assessment Criteria: The study will be strictly based on assessment of subjective parameter by the grading them. The data obtained will be analyzed statistically. Observation and Results: Observation and results will be drawn according to assessment criteria. Discussion: The observed phenomena will be discussed. Conclusion: Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased Summary: The research study will be summarized in brief. Ethical Consideration: The study will be conducted in accordance with ethical guidelines and inform consent from participant. |