A Randomized comparative clinical study to evaluate the efficacy of vedanasthapana anal suppository and vedanasthapana taila matrabasti in the management of kashtartava (Primary dysmenorrhea)
- Conditions
- Primary dysmenorrhea. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH,
- Registration Number
- CTRI/2023/07/055586
- Lead Sponsor
- Parul Ayurved Hospital
- Brief Summary
INTRODUCTION:
Dysmenorrhea is the most common gynecological problem faced by womenduring their adolescence. It causes significant discomfort and anxiety for thewoman as well as her family. A systematic review of studies from developingcountries revealed that about 25%–50% of adult women and about 75% ofadolescents experience pain during menstruation, with 5%–20% reporting severedysmenorrhea or pain that is severe enough to prevent them from carrying outtheir day-to-day activities1. The word Kashtartava itself gives anidea of the difficulty experienced during menstruation2. Kashtartavacan be taken to be the same as the ‘dysmenorrhea’ of modern medicine. Primarydysmenorrhea is a condition which causes painful menstruation without anydemonstrable pelvic pathology3. In addition to menstrual pain, manywoman experience associated symptoms such as headache, constipation, nausea,vomiting, fatigue, and leg pains. The etiology of uterine pain in primarydysmenorrhea is still not established. But several risk factors have beenidentified, such as young age, early menarche, positive family history,nulliparity, stress/depression, and smoking. There are many theories regardingthe pathophysiology of the condition4, with the prostaglandin theorybeing the one that is most generally accepted. The treatment usually advocatedin modern medicine, i.e., analgesics, antispasmodics, and/or oral contraceptivepills5, does not provide a long-lasting solution and, besides, maylead to serious adverse effects. Over 25% of women experience menstrualdiscomfort that is resistant to treatment6. As yet there is notreatment regimen that can relieve the entire symptom complex of primarydysmenorrhea. Hence, there is a need to find a safe and long-lasting treatmentfor the condition. Kashtartava, especially when it manifests as primarydysmenorrhea, is a Vata-dominant condition and can be co-related withUdavartini yonivyapad. The treatment protocol of Udavartini yonivyapad suggestsmatrabasti so the study is aimed at matrabasti and development of innovativedrug delivery method in the form of anal suppository. The drugs selected hereare Vedanasthapana Gana dravyas which not only pacifies pain but also pacifiesvitiated vaat dosha.
NEED OF WORK:
Prevalence of dysmenorrhea is 70.2% in Indian population7.While comparing prevalence of dysmenorrhea from other countries, Ethiopiareported 70% dysmenorrhea wherein 28.5% had moderate to severe, Malaysiareported an incidence of 6.8% having moderate to severe pain and Jordanreported 55.8% of the subjects had moderate to severe pain. Majority of thesubjects experienced pain for one or 1-2 days during menstruation. 23.2% of thedysmenorrheic girls experienced pain for 2-3 days. The most common symptom inboth dysmenorrheic and non dysmenorrheic girls during the menstrual periods wastiredness and second most prevalent symptom was back pain. Females experiencingmild pain on an average absented for one and half day a month while 2.1±1.2 and2.5±1.3 days for those who experienced moderate and severe forms ofdysmenorrhea respectively
An extremely significant association was found between the severity ofdysmenorrhea and limitation in working capacity of females. An inverserelationship is exhibited between severity of dysmenorrhea and percentage offemales reporting unaffected working ability while a proportional increase canbe seen in percentage of females reporting clear inhibition of working ability.
Studies have demonstrated that menstrual pain restricts the movement andusual activity pattern of the females. It could also be argued that theperception of uneasiness and discomfort experienced during menstruationprobably limits the movements more than the experience of pain. It is a pointof concern since it is an indication of discomfort and poor work efficiency ofthe person.
So the study is focused on Dysmenorrhoea and finding an easy, effective,safe and feasible way for its management.
RESEARCH QUESTION:
• Isvednastapana anal suppository and vedanasthapana taila matrabasti effective inprimary dysmenorrhea?
AIM: To study the efficacy of Vedanasthapana anal suppository andvedanasthapana taila matrabasti in Primary dysmenorrhea
OBJECTIVES:
1. To evaluate the efficacy of Vedanasthapana anal suppository in Primary dysmenorrhea
2. To evaluate the efficacy of Vedanasthapana taila Matrabasti in Primary dysmenorrhea
3. To evaluate the comparative efficacy of Vedanasthapana anal suppository and Vedanasthapana taila Matrabasti in Primary dysmenorrhea
PREVIOUS WORK DONE:
1. Acomparative study of Dashamoola Taila Matra Basti and Tila Taila Matra Basti inKashtartava (dysmenorrhea) Kaumadi Karunagoda, Kamayani Shukla (Upadhyaya),Shilpa Donga, Chandrika Tanna1 , L. P. Dei Department of Stree Roga andPrasooti Tantra, Institute for Post Graduate Teaching and Research in Ayurveda,Gujarat Ayurved University, Jamnagar, 1 Gynaecologist and Obstetrician, JeevanDeep Hospital, Jamnagar, India.
2. Role of *Uttara Vasti* with *Trivrit* and *Lasuna* oilin the management of primary dysmenorrhea [Shabnam Jahan](https://pubmed.ncbi.nlm.nih.gov/?term=Jahan%20S%5BAuthor%5D), [N. Sujatha](https://pubmed.ncbi.nlm.nih.gov/?term=Sujatha%20N%5BAuthor%5D), and [Neelam](https://pubmed.ncbi.nlm.nih.gov/?term=Neelam%20%5BAuthor%5D)
3. Efficacyof Dasamula Taila Matrabasti in Udavartini Yonivyapad Dr. Simpy Dowarah1 , Dr.Kaushalya Khakhlary2 1 PG Scholar, Dept. of Prasuti Tantra and Stree Roga,Govt. Ayurvedic College & Hospital, Guwahati-14 2Associate Professor, Dept.of Prasuti Tantra and Stree Roga, Govt. Ayurvedic College & Hospital,Guwahati-14
HYPOTHESIS:
• NullHypothesis(H0): Neither Vedanasthapana anal suppository nor vedanasthapanataila matra basti is effective in Primary dysmenorrhea
• AlternateHypothesis(H1): Vedanasthapana anal suppository is more effective thanvedanasthapana taila matra basti in Primary dysmenorrhea
• AlternateHypothesis(H2): Vedanasthapana taila matra basti is more effective thanVedanasthapana anal suppository in Primary dysmenorrhea
• AlternateHypothesis(H3): Both Vedanasthapana anal suppository and vedanasthapanataila matra basti are equally effective in Primary dysmenorrhea
METHODOLOGY:
· STUDYDESIGN:
An openlabelled, randomized, Comparative, Interventional, Prospective Clinical study.
· SELECTIONOF PATIENTS:
Minimum of 100 Patients attending the IPD & OPD of Parul AyurvedHospital, diagnosed with primary dysmenorrhea would be enrolled in the studywith prior consent.
The samples will be selected by random sampling method (ComputerizedRandomization). Patients will be equally divided into two trial groups,each group containing 50 patients.
· SAMPLESIZE CALCULATION:
TheSample size for the above said study is calculated using Standard Sample SizeFormula (Cochran’s Formula):
n=z2(pq)/e2
n = Sample Size
z = Standard Error associated with the chosen level of confidence(Typically 1.96)
p = Variability / Standard Deviation=Prevalence rate
q = 1-p
e = Acceptable sample error
Withreference to above formula, the sample size was calculated considering 70.2%prevalence rate36, 20% allowable error and 95% of confidence level.
TheObtained sample size is 40.76
Expectinga dropout rate of 25% in the number of patients to be enrolled in the study,the final sample size was fixed as 50 per group.
· INCLUSIONCRITERIA
i. Patientswith chief complaint of lower abdomen pain during menstruation with regularcycle (21-35 days) with VAS score more than 4.
ii. Agegroups between 18 to 30 years shall be selected.
iii. Patientssuffering from dysmenorrhea for at least 3 cycles in last 6 months.
iv. Marriedand unmarried women will be incorporated for the study.
v. Patientsfit for matrabasti and suppository use.
· EXCLUSIONCRITERIA:
i. Anyspace occupying lesion.
ii. Womenwith Irregular menstrual cycles.
iii. Secondarydysmenorrhea.
iv. IUCD
v. Womendiagnosed with congenital anomalies of reproductive tract.
vi. Systemicor metabolic disorders which can be contraindicated for matrabasti orsuppository use.
· INTERVENTIONPROTOCOL:
Group A- Anal Suppository group
Preparation-Vedanasthapana gana suppository will be prepared in Pharmacyof Parul Institute of Ayurved.
Dose- 2 gm suppository will be inserted per anal for 5 days (twice day)
Time of Administration: 7 days prior to expected date of menstruation
Duration- Consecutive 2 cycles
Group B- Matrabasti group
Preparation-Vedanasthapana gana taila will be prepared in Pharmacy ofParul Institute of Ayurved. Tail will be prepared as per Snehapaak vidhimentioned in Sharangdhar Samhita
Dose- 60 ml for 5 days (once a day)
Time of Administration: 7 days prior to expected date of menstruation
Duration- Consecutive 2 cycles
Rescue Medicine: PCM/Mefenamic acid
· INVESTIGATIONS
Routine hematological and urinary examinations will be done beforetreatment. Sonography to rule out uterine and adnexal pathology will be done asper need.
· STUDYCENTRE:
Study will be conducted at Parul Institute of Ayured(PIA), ParulInstitute of Ayurved and Research (PIAR) and Parul Ayurved Hospital, Vadodara.
· SOURCESOF DATA
a) LiterarySource-All classical, modern literature and contemporary texts includingjournals and websites about the disease, drugs and procedures will be reviwedand documented for the study.
b) PharmaceuticalSource- Vedanasthapana Gana anal Suppository and Taila will be prepared in theGMP certified Pharmacy of Parul Institute of Ayurved.
c) ClinicalSource- Patients who are ready to give consent will be included from ParulAyurved Hospital.
· CRITERIAOF ASSESSMENT
1. WaLIDDScore39
2. Effecton Menstrual Pain-VAS Score40
3. AssociatedComplaints score41
4. Improvementin Quality of Life- SF-36 (RAND) questionnaire42,43
1. WaLIDD Score: Assessment will be done on 1st and 5th day of each cycle
2.VAS Score
3. Associated Symptoms:
| | | | | | |
| --- | --- | --- | --- | --- | --- |
|Sr No.
Symptoms
Grade 0
Grade 1
Grade 2
Grade 3
|1
Vedana (pain)
Menstruation is not painful and patient can carry out her daily activities.
Menstruation is painful but daily activity is not affected
Menstruation is painful and patient uses an analgesic drug to get relief.
Menstruation is very painful that the patient is unable to carry out her daily works.
|2
Artavapramana (amount of bleeding)
6-7 pads/cycle
4-5pads/cycle
2-3 pads/cycle
Spotting during
menses, 1 pad/cycle
|3
Chardi (vomiting)
Absent
Occasional
1-2 episodes of vomiting
Vomiting present when pain occurs and persists throughout menstruation
|4
Atisara(Diarrhoea)
Absent
occasional
2-3 times/day
More than 3
episodes of diarrhoea/day
|5
Vibandha(constipation)
Absent
Stool passed daily but constipated
Stool passed on alternate days
Stool not passed even for 3-4 days
|6
Shrama(fatigue)
Absent
Fatigue induced by even single extra work in addition to the daily routine
Fatigue induced by doing simple routine work
Severe fatigue even without work
|7
Aruchi(loss of appetite)
Takes a full diet and also has proper appetite at the next meal time
Moderate appetite and appearance of appetite for next meal
Low appetite and delayed appearance of appetite in next meal
Persisting low appetite or frequent loss of appetite; unable to consume even the minimum required diet
|8
Shirashula(Headache)
Absent
Headache once during each menstruation; persists for less than 6 h
Frequent headache 2–3 times per menstruation; daily activity not affected
SeverePersistent headache throughout the menstruation; daily activity affected
|9
Vankshana Shula (tenesmus of the bladder), Kati Shula, and Janu Shula
Absent
Presence of all three for less than 1 h / any two features for less than 6 h / any one feature for less than 12 h
Presence of all three for 1–2 h / any two features for 6–12 h / any one feature for more than 12 h
Presence of all three for more than 2 h / any two features for 12–24 h / any one feature for more than 24 h
|10
Swedadhikya(Excessive sweating)
Absent
Occurs only on working in a hot environment or doing hard work
More in the day time / associated with or following hot flushes only
Excessive sweating to the extent that the patient needs to change her clothes or have a bath
|11
Tamodarshana (faints)
Absent
Occasionally
Faints once during each menstruation
More than once during each menstruation
• Scoringof associated Symptoms
| | |
| --- | --- |
|Number of symptoms seen
Score
|0
Grade 0
|1-12
Grade 1
|13-24
Grade 2
|25-36
Grade 3
4. Improvement in Qualityof Life- SF-36 (RAND) questionnaire Score:
· Overalleffect of the intervention will be estimated in the following 5 categories:
| | |
| --- | --- |
|Result
Observation
|No relief
0% relief in the signs and symptoms
|Mild relief
(1 to ≤ 25%) relief in the signs and symptoms
|Moderate Relief
(>25 to ≤ 50%) relief in the signs and symptoms
|Significant relief
(>50 to ≤ 75%) relief in the signs and symptoms
|Excellent Relief
(>75%) relief in the signs and symptoms
· STUDYDURATION: 18 months
· ASSESSMENTAND FOLLOW UP:
Initial assessment at the time of enrolment (BT) then assessment during1st menstrual cycle, 2nd menstrual cycle andfollow up for next 2 consecutive cycles (AT).
WaLLID score will be assessed on first and last day of each menstrualcycle.
Assessments at intervals- 0, MC1, MC2, MC3, MC4
· STATISTICALANALYSIS:
Collected data and observation will be analyzed critically andscientifically by employing statistical tests.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 100
- i.Patients with chief complaint of lower abdomen pain during menstruation with regular cycle (21-35 days) with VAS score more than 4.
- ii.Age groups between 18 to 30 years shall be selected.
- iii.Patients suffering from dysmenorrhea for at least 3 cycles in last 6 months.
- iv.Married and unmarried women will be incorporated for the study.
- v.Patients fit for matrabasti and suppository use.
- i.Any space occupying lesion.
- ii.Women with Irregular menstrual cycles.
- iii.Secondary dysmenorrhea.
- iv.IUCD v.Women diagnosed with congenital anomalies of reproductive tract.
- vi.Systemic or metabolic disorders which can be contraindicated for matrabasti or suppository use.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of vedanastapana anal suppository and vedanasthapana taila matrabasti in the management of kashtartava(primary dysmenorrhea) baseline, consecutive 4 menstrual cycles for 4 months
- Secondary Outcome Measures
Name Time Method Evaluate the efficacy of vedanastapana anal suppository & vedanasthapana taila matrabasti in the management of kashtartava (primary dysmenorrhea) & in consecutive cycles after 2 months of treatment consecutive 2 menstrual cycles after 2 cycles of treatment
Trial Locations
- Locations (1)
Parul Institute of Ayurved
🇮🇳Vadodara, GUJARAT, India
Parul Institute of Ayurved🇮🇳Vadodara, GUJARAT, IndiaDr Nirmala Ramesh SonawanePrincipal investigator8329614671ayurved05@gmail.com