| CTRI Number |
CTRI/2025/08/092861 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Controlled Clinical Trial To Assess The Effect Of Kuberaksh Vati And Rajaparvartini Vati In The Management Of Primary Dysmenorrhoea. |
|
Scientific Title of Study
|
A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy Of Kuberaksh Vati And Rajaparvartini Vati In The Management Of Udavartini Yonivyapad W.S.R. 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 Manju |
| Designation |
MS Scholar Stree Roga Prasuti Tantra |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
Opd No 15 Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9518011154 |
| Fax |
|
| Email |
dr.manjukadian02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suniti Tanwar |
| Designation |
Professor, Department Of Stree Roga Prasuti Tantra |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
Room No 112 PG Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9996311778 |
| Fax |
|
| Email |
drsunititanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju |
| Designation |
MS Scholar Stree Roga Prasuti Tantra |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
Opd No 15 Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9518011154 |
| Fax |
|
| Email |
dr.manjukadian02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research Sector Kurukshetra Haryana |
| Address |
Umri Road Sector 8 Kurukshetra Haryana 136118 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manju |
Institute For Ayurved Studies And Research |
Opd NO 15 Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana 136118
Kurukshetra
HARYANA |
9518011154
dr.manjukadian02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SKAU KURUKSHETRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N889||Noninflammatory disorder of cervixuteri, unspecified. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: RAJAPARVARTINI VATI, Reference: Bhaishajya Ratnavalia Streeroga Adhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KUBERAKSH VATI, Reference: Brihat Nighantu Ratnakar Shooladhyaya 23, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient Willing To Give Voluntary Informed Consent
Age Group Between 16-35 Years Both Married And Unmarried Women
Pain In The Lower Abdomen Which Begin One Or Two Days Before Menstruation Or With The Onset Of Menstruation And Lasting For Few Hours Or One To Two Days
Painful Menstruation Also Associated With Symptoms Like Nausea Vomiting Constipation Etc
History Of Painful Menstruation For Atleast 3 Consecutive Cycles
Patient Diagnosed With Dysmenorrhoea
Patient With Regular Menstrual Cycle 21 To 35 Days |
|
| ExclusionCriteria |
| Details |
Patient Who Is Not Willing To Give Voluntary Informed Consent
Patients Taking Any Hormonal Therapy
Patients Of Any Pelvic Pathology PCOD PID Cervical stenosis Fibroid Endometriosis Adenomyosis Etc
Patients With Congenital Anomalies Of Reproductive System
Other Medical Disorders Which Make Patients At High Risk Like Epilepsy Anaemia Hb Less Than 8mg/dl Heart Disease DM
Surgical And Malignant Conditions
Heavy Bleeding During Menses Patients Are Excluded More Than 4 Pads Fully Soaked Per Day |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change In The Grade Of VAS Visual Analogue Score Scale Of Pain |
Follow Up Will Be Done on Day 4 Of Three Consecutive Cycles And 120th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CHANGES IN OTHER ASSOCIATED CLINICAL SYMPTOMS LIKE NAUSEA VOMITING ETC |
Follow Up Will Be Done On Day 4 Of Three Consecutive Cycles And 120th day |
|
|
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 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PRIMARY DYSMENORRHOEA IS PAINFUL MENSTRUAL CRAMP ORIGINATING IN THE LOWER ABDOMEN COMMONLY EXPERIENCED BEFORE OR DURING MENSTRUATION WHICH AFFECTS DAY TO DAY ACTIVITES. PRIMARY DYSMENORRHOEA IS NOT ASSOCIATED WITH ANY PELVIC PATHOLOGY. IN AYURVEDA IT CAN BE CORRELATED WITH UDAVARTINI YONIVYAPAD. IN UDAVARTINI YONIVYAPAD DOSHA INVOLVEMENT OF VATA. VATA IS A SIGN OF PAIN AND ALL GYNACOLOGICAL DISEASE OCCUR DUE TO APANA VATA DUSHTI. PATIENTS WITH PRIMARY DYSMENORRHOEA WILL BE REGISTERED IN 2 GROUPS (30 IN EACH GROUP). GROUP A GIVEN KUBERAKSH VATI AND GROUP B RAJAPARVARTINI VATI ON 7 DAYS BEFORE EXPECTED DATE OF MENSES FOR 10 DAYS.
PAIN ASSESMENT OF DYSMENORRHOEA DONE BY VAS SCALE (1-10 SCORE) AT THE LAST OF TRIAL OBSERVE CHANGE IN THE GRADE OF VAS SCALE PAIN. |