| CTRI Number |
CTRI/2025/06/089734 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the results of Kuberaksha Vati and Dashmoola Taila Matra Basti in patients having pain during menstruation |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Kuberaksha vati and Dashmoola Taila Matra Basti in the management of Udavartini yonivyapad with special reference to primary dysmenorrhea. |
| 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 Shubhi Mishra |
| Designation |
MS Scholar ( Prasuti Tantra evum Stri Roga) |
| Affiliation |
State Ayurvedic College and Hospital, Tulsidas marg, Turiyaganj, Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga ,State Ayurvedic College and Hospital, Tulsidas marg,
Turiyaganj ,Lucknow, Uttar pradesh, India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7080932612 |
| Fax |
|
| Email |
mshubhi71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Sharma |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital, Tulsidas marg, Turiyaganj, Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga ,State Ayurvedic College and Hospital, Tulsidas marg,
Turiyaganj ,Lucknow, Uttar pradesh, India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8743976379 |
| Fax |
|
| Email |
drshikhasharma1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhi Mishra |
| Designation |
MS Scholar ( Prasuti Tantra evum Stri Roga) |
| Affiliation |
State Ayurvedic College and Hospital, Tulsidas marg, Turiyaganj, Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga ,State Ayurvedic College and Hospital, Tulsidas marg,
Turiyaganj ,Lucknow, Uttar pradesh, India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7080932612 |
| Fax |
|
| Email |
mshubhi71@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital ,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital , Tulsidas marg, Turiyaganj ,Lucknow , Uttar Pradesh ,India |
| Address |
PG Department of Prasuti Tantra Evum
Stri Roga ,State Ayurvedic College and
Hospital ,Tulsidas marg, Turiyaganj,
Lucknow, Uttar pradesh, India |
| Type of Sponsor |
Government 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 Shubhi Mishra |
State Ayurvedic College and Hospital, Tulsidas marg,Turiyaganj, Lucknow |
PG Department of Prasuti Tantra evum Stri Roga, State Ayurvedic College and Hospital, Tulsidas marg,Turiyaganj, Lucknow
Lucknow
UTTAR PRADESH |
7080932612
mshubhi71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Committee |
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: Kuberaksha Vati, Reference: Brihat Nighantu Ratnakar Shool Rogadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: dose- 2 tablets BD 250 mg each orally for 3 consecutive months. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmoola taila matra basti, Reference: Charak Samhita Chikitsasthan 30/110-111, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Per rectal 7 days before the expected date of menses |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.female patient of age 16 to 35 years.
2.Patient suffering from pain during mensuration for more than 3 consecutive cycle.
3.Patient coming with chief complaint of pain during menses with or without associated symptoms.
4. Patient willing and able to participate in study. |
|
| ExclusionCriteria |
| Details |
1.Female patients age below 16 years and above 35 years of age.
2.Patients with any identifiable pelvic pathology like fibroids, adenomyosis, endometriosis, PID, UTI etc.
3.Patients using IUD /oral contraceptive pills.
4.Patient have H/O hypothyroidism and hyperthyroidism with DUB .
5.Patients with systemic disorders like Tuberculosis, Hypertension, Diabetes mellitus, anemia etc.
6.Patient not willing for trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of Kuberaksha vati and Dashmoola taila matra basti in the management of udavartini yonivyapad.
2.To compare the efficacy of Kuberaksha vati and Kuberaksha vati with Dashmoola Taila Matra Basti. |
1.after 4 weeks
2.after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Conceptual Study of Udavartini Yonivyapada.
2.To find out safe & potent drug for Udavartini Yonivyapada.
3.Decrease in pain during menses.
4.reduction in associated menstrual problems.
5.To evaluate any adverse effects associated with treatment. |
1.after 4 weeks
2.after 4 weeks |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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="6"
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
|
This is a Randomised, comparative clinical study Phase 2 Parallel group trial. Comparing the efficacy of Kuberaksha vati and Dashmoola taila Matra Basti in cases of Udavartini Yonivyapad for 3 months in 40 patients. The patient fulfilling the clinical criteria for diagnosis of Udavartini Yonivyapad will be randomly selected from OPD/IPD of state Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed. Further patient divided into two groups, Group-A- In this group patients will be treated with Kuberaksha vati orally 2 tabs BD (250 mg each) with lukewarm water after meal for the period of 3 months. Group-B- In this group patients will be treated with Kuberaksha vati orally 2 tabs BD (250 mg each) with lukewarm water after meal for the period of 3 months along with Dashmoola taila Matra Basti per rectal in the dose of 60 ml for the period of 7 days before the expected date of menses. Follow up period will be 30 days after the completion of trial. |