| CTRI Number |
CTRI/2024/04/066091 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Inervention For Painful Menses |
|
Scientific Title of Study
|
An open labelled randomised controlled clinical study to
evaluate the efficacy of Shoolaprashamana Mahakashaya phanta versus Mefenamic acid in Kashtartava 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 |
Neetika |
| Designation |
Pg Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh Prasuti Tantra and Stree Roga OPD Room No 105A
Chandigarh
CHANDIGARH
160047
India |
| Phone |
7988351178 |
| Fax |
|
| Email |
nitika79684@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Maganti |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh Prasuti Tantra and Stree Roga Room No 105A
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9043940396 |
| Fax |
|
| Email |
dranuradha98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neetika |
| Designation |
Pg Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh Prasuti Tantra and Stree Roga Room No 105A
Chandigarh
CHANDIGARH
160047
India |
| Phone |
7988351178 |
| Fax |
|
| Email |
nitika79684@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh Pincode 160047 India Prasuti Tantra and Stree Roga OPD Room No 105A |
|
|
Primary Sponsor
|
| Name |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh Pincode 160047 India Prasuti Tantra and Stree Roga OPD Room No 105A |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Neetika |
Shri Dhanwantry Ayurvedic College and HospitalSector 46 B Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Neetika |
Shri Dhanwantry Ayurvedic College and Hospital |
Sector 46 B Chandigarh Pincode 160047 India Prasuti Tantra and Stree Roga OPD Room No 105A
Chandigarh
CHANDIGARH |
07988351178
nitika79684@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SHRI DHANWANTRY AYURVEDIC COLLEGE& HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Mefenamic Acid | Allopathic Medicine
Dose 500mg initial single dose followed by 250mg 6 hourly
Oral Route
Twice a day After meal
3 Menstrual Cycles From the onset of menstrual pain to 3 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shoolaprashamana Mahakashaya Phanta, Reference: Charak Sutra 4, Route: Oral, Dosage Form: Phanta, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Ayurvedic Medicine Dose 48ml BD Oral Route Twice a day before meal 3 Menstrual Cycles From the onset of menstrual pain to 3 days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
H/O Painful menstruation and pain few days prior to menstruation for atleast three consecutive cycle.
Age group of 15-49 year
Patients having moderate to severe pain acc to MRC grading recommended by WHO
Patient suffering from any type of menstrual pain premenstrual pain and average bleeding during periods that persisted for 3 months prior to the study will be included
Patients with fibroids less than 3cm who had secondary dysmenorrhoea without menorrhagia
Endometriosis Adenomyosis with regular periods and average bleeding during periods that persisted for 3 months prior to the study will be included
|
|
| ExclusionCriteria |
| Details |
Carcinoma
Tuberculosis
Congenital anomalies
Patient on hormonal therapy
Patient who had pain caused by inflammatory or malignant diseases
Patients were taking oral contraceptive pill IUCD suffered from chronic general illness lactating women
Uterine fibroids of size greater than 3cm with menorrhagia
Patient having irregular periods
Abnormal Uterine Bleeding
Menstrual Pain associated with Menorrhagia and Metrorrhagia
Ovarian Cyst greater than 6cm
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in scoring of VAS and MRS grading 80% reduction |
Baseline 1st 2nd and 3rd Menstrual Cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in associated systemic symptoms Nausea Vomiting Headache Fatigue Diarrhoea |
Baseline & 3rd 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)
|
01/05/2024 |
| 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="4"
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
Modification(s)
|
Topic An Open Labelled Randomised Controlled Clinical Study To Evaluate The Efficacy of Shoolaprashamana Mahakashaya Phanta Versus Drotaverine In Kashtartava Dysmenorrhea Introduction Dysmenorrhea characterized by painful menstruation, is a common gynecological issue affecting a significant portion of women worldwide. Shoolaprashamana Mahakashaya phanta an Ayurvedic formulation is proposed as an alternative treatment to conventional medication like Drotaverine . This study aims to compare the efficacy of these two treatments in managing dysmenorrhea. Materials and Methods An open-label, randomized controlled clinical study will be conducted at Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh. Sixty patients diagnosed with dysmenorrhea will be divided into two groups with one receiving Shoolaprashamana Mahakashaya phanta (48ml BD) and the other receiving Drotaverine(40mg TDS). Pain intensity will be assessed using Medical Research Council (MRC) grading and Visual Analog Scale (VAS). Associated symptoms will also be evaluated. Statistical analysis will be performed using SPSS version 20. Expected Outcomes The study aims to evaluate efficacy of Shoolaprashamana Mahakashaya phanta in reduction in pain scores of VAS and MRS grading and associated symptoms from baseline to the third menstrual cycle as compared to Drotaverine. Discussion Shoolaprashamana Mahakashaya phanta may be a promising alternative to conventional medication for managing dysmenorrhea. Its efficacy in reducing pain and associated symptoms warrants further investigation in larger, long-term studies.
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