| CTRI Number |
CTRI/2022/04/041911 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Ayurvedic Treatment for Primary Dysmenorrhea Kashtartava |
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Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY OF MENOCRAMP TABLET AND SAPTASARAM GHAN VATI IN THE MANAGEMENT OF KASHTARATVA (PRIMARY DYSMENORRHEA) |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Sharma |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda, Parul University |
| Address |
309 Department of PTSR Parul Institute of Ayurveda P O Limda Tal Waghodia
Vadodara GUJARAT 391760 India |
| Phone |
9915851262 |
| Fax |
02668-260201 |
| Email |
drnid31@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Asokan V |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda, Parul University |
| Address |
309 Department of PTSR Parul Institute of Ayurved P O Limda Tal Waghodia
Vadodara GUJARAT 391760 India |
| Phone |
6361740431 |
| Fax |
02668-260201 |
| Email |
drasokan24@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Asokan V |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda, Parul University |
| Address |
309 Department of PTSR Parul Institute of Ayurved P O Limda Tal Waghodia
Vadodara GUJARAT 391760 India |
| Phone |
6361740431 |
| Fax |
02668-260201 |
| Email |
drasokan24@gmail.com |
|
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Source of Monetary or Material Support
|
| Soulmiks Herbaceuticals Limited |
|
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Primary Sponsor
|
| Name |
Solumiks Herbaceuticals Limited |
| Address |
135 Nanubhai Desai Road Khetwadi Mumbai 400004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Sharma |
Teaching Hospital of Parul Ayurveda Hospital |
Room no 104 OPD of Department of PTSR Parul Institute of Ayurveda Parul University PO Limda Tal Waghodia Vadodara GUJARAT |
9915851262 02668-260201 drnid31@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PIA PU |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saptasaram Kwath Ghan Vati , Reference: Sahasra Yoga Kasahya Prakarana 284 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: 5 days in a month during menstrual phase | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Menocramp tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: 5 days in a month during menstrual period |
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Women between the age group 15 to 30 years.
2. Women with regular cycle with painful menstruation.
3. Women without any pelvic pathology.
4. Be able and willing in the view of the investigator to comply with all study procedures and sign informed written consent form.
|
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| ExclusionCriteria |
| Details |
Women with history of PID endometriosis and debilitating pathological conditions of the pelvic organs, systemic diseases like diabetes mellitus bronchial asthma tuberculosis thyroid dysfunction with organic lesion benign or malignant growth of reproductive tract uterine prolapse and Hypo-plastic uterus
Women with congenital anomalies of genital organs
Polycystic ovarian disease
Patients with chronic hepatic neurological or orthopedic conditions neuropsychiatric illness malignancy or AIDS
Subjects rejecting to sign the consent form drug addicts
Patients with clinically significant cardiovascular, hematological, pancreatic metabolic neurological disorders or clinically significant laboratory abnormalities which in the judgement of the investigator would interfere with the subjects participation in the study or evaluation of the subjects response to therapy
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
pain relief
relief in associated complaints |
1 month with 1 month follow up |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| psychological relief and improvement in QoL of participants |
1 month during study and during follow up period |
|
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Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/04/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
In our society women is compared to mother earth as both have the quality of forbearance and procreation. Dysmenorrhea is a medical condition of painful menstruation of sufficient magnitude so as to incapacitate day to day activities . The prevalence rate of dysmenorrhea in adolescent girls is 70.2% in india. According to Acharaya Sushruta , pain is indication of vata vikruti. Ø Majority of previous works carried out were either based on procedure like Uttarbasti or were based on basti. Since it is impossible for uttar basti to be performed on unmarried patients, and also the young those hesitate to undergo Matra Basti who are the most sufferers. Only few works have been done on oral form of medicine for the treatment of Kashtartava. Ø Till date, no successful advances have been made in the management of Primary dysmenorrhea by conventional medicine. The best evidence-based treatments are NSAIDs and hormonal contraceptives but they have a lot of side effect. Ø According to Ayurveda, pain is an indication of Vata Vikriti. Vitiated Apana Vata is considered as the primary cause for Yoni vikara’s. Hence, all measures capable of suppressing Vata are indicated. AIM: The present study has been planned to accomplish following aims and objective: · To evaluate and compare the efficacy of “Saptasaram ghan vati†with Menocramp tablets in the management of Kashtartava. OBJECTIVE: · To evaluate the effect of drug on associate complaints of dysmenorrhoea. · To assess the efficacy of drug in reducing the psychological complaints associated with dysmenorrhoea. HYPOTHESIS: · Null Hypothesis (H0): Saptasaram ghan vati is not effective in the management of Kashtartava when compared to Menocramp tablets. · Alternate Hypothesis (H1): Saptasaram ghan vati is more effective in the management of Kashtartava when compared to Menocramp tablets.
Diagnostic Criteria: · Painful menstruation of acute and spasmodic nature · Pain of sufficient magnitude to hamper the routine daily activities for 48 - 72 hours duration in regular menstrual cycles. · Associated with or without constipation, loose stools, nausea, breast tenderness, mood swings, headache, giddiness, irritability. Study Duration: · 1 menstrual cycle · Medicine will be given from first day of menses till 5th day of menses for one cycle · Follow up for next one menstrual cycle without medicine for both groups. Assessment of Pain (Dysmenorrhea): VISUAL ANALOGUE SCALE | NO PAIN (0) | ANNOYING (MILD) (2 TO 3) | UNCOMFORTABLE (MODERATE) (4 TO 6) | HORRIBLE (SEVERE) (7 to 9) | WORST (10 ) | WaLIDD SCORE VARIABLE | Working ability | Location | Intensity | Days of Pain | | 0 None | 0 None | 0 Does not Hurt | 0 Zero | | 1 Almost never | 1 one site | 1 Hurts a little bit | 1 One- Two | | 2 Almost always | 2 two – three sites | 2 Hurts a little more- hurts even more | 2 Three- Four | | 3 Always | 3 four sites | 3 Hurts a whole lot – hurts worst | 3 >Five | Notes: Score 0 without Dysmenorrhea, 1- 4 mild Dysmenorrhea, 5-7 moderate Dysmenorrhea, 8-12 severe Dysmenorrhea. |