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A. Conceptual study B. Clinical
Study
A. CONCEPTUAL STUDY :
The available literatures on related drugs, Garbhashaya-yoni bhramsha and Utero vaginal prolapse shall be
collected from different Ayurvedic text, modern text, reputed journals
and retrospective studies done in various institutions.
·
On the analysis of all review literatures,
conceptual hypothesis is being made to evaluate the effect of oral
administration of Ashwagandha churna and
Madanphaladi pottli in the registered patients of garbhashaya- yoni bhramsha w.s.r. to utero-vaginal prolapse.
B. CLINICAL
STUDY
1. Sample Source : All the patients will be registered from
the OPD and IPD of PG Department of Prasuti Tantra and Stri Roga, State
Ayurvedic College and Hospital, Lucknow, UP.
In the present clinical study the
patient of age group of 35-60 years will
be registered for proposed clinical trial.
2. Type of Study : Randomized
comparative parallel open clinical trial.
3. Sample
size : Minimum
40 patients in two groups will be registered.
Group Allocation :
Registered patients will be randomly
divided into two groups :
Group-A : This group of patients both of reproductive
age group and menopausal one will be
given the trial drug Ashwagandha churna orally for 3 continuous months
& Madanphaladi Pottali locally for 10 consecutive days after
clearance of menses in reproductive age grouped patients for 3 continuous
cycles and 10 consecutive days every month for menopausal patients for 3
continuous months.
Group-B : The reproductive age group patients of
this group will be given the trial drug Madanphaladi Pottali locally for
10 consecutive days after clearance of menses in reproductive age group
patients for 3 continuous cycles and in
menopausal patients for 10 consecutive
days every month for 3 continuous months. TRIAL DRUG/THERAPY DRUG
STANDARDIZATION and SAFETY PROTOCOL : The
raw material for trial drug will be purchased from the authentic Ayurvedic
aushadhi bhandar and available raw drugs will be verified for the clinical
trial by the Department of Dravyaguna before
preparation for clinical trial. The trial drug will be prepared in the pharmacy
of State Ayurvedic College, Lucknow by concerned experts and under the
supervision of Department of RasaShashtra & Bhaishajya Kalpana. MODE OF ADMINISTRATION : The trial drug shall be administered orally and
locally in the form of churna and pottali respectively. 1.Ashwagandha Churna : Dosage :
5 gm of Ashwagandha churna BD. Anupan : Ashwagandha
churna will be advised with lukewarm milk. Frequency of medication : 5 gm of Ashwagandha churna will be given for trial in morning and evening
daily for 3 continuous months in both reproductive age grouped and menopausal
patients. 2. Madanphaladi Pottli : Dosage : 12 gm Pottali will
be kept intravaginally. Dharana Kal : Patient will be asked to evacuate her bladder before
dharana of Madanphaladi pottali and it will
be kept till next urge of urine (approx. 3-4 hours). Frequency of medication : 12 gm pottali
will be kept intravaginally for 10 consecutive
days
after clearance of menses in reproductive age grouped patients for 3 continuous
cycles and in menopausal patients for 10 continuous days every month for 3
months. DURATION
OF TRIAL & FOLLOW UP : Duration of trial : It will be trial of 4 consecutive months. 3 months
with clinical therapy and 1 month drug free follow-up. Follow
up during treatment : The
trial of local drug will be given for 3 consecutive cycles after clearance of
menses in reproductive age grouped patients and at the interval of 20 days of every month in
menopausal patients for 3 continuous months. The trial of oral drug will be given regularly for 3
months in both reproductive age grouped patients and menopausal patients.
Follow
up: Follow up of all the patients will be for 4 months
and last month will be drug free. CRITERIA FOR SELECTION OF PATIENTS : A. Pre-assessment criteria
: Patients from Prasuti
tantra and Stri roga OPD and IPD will be screened out by the symptoms. B. Diagnostic
Criteria : Diagnosis
will be based on the presence of cardinal and associated symptoms of garbhashaya-yoni bharmsha. Cardinal symptoms - ·
Feeling of something coming down per vaginum ·
Backache
or dragging pain in the pelvic region. ·
Feeling
of heaviness in pelvic region ·
Variable
discomfort and pain on movement. ·
Pain
in change in posture ·
Vaginal
discharge Associated
Symptoms – ·
Burning
micturition ·
Painful
micturition ·
Increased
frequency of micturition ·
Constipation ·
Dyspareunia C.
Gyneacological Examinations :
a. Inspection of Vulva – ·
Healthy
or Unhealthy ·
b. Per
Speculum Examination- ·
Cervical congestion
·
Vaginal
discharges ·
Vaginal
wall laxity ·
c. Per Vaginal
Investigation - ·
Cervical tenderness ·
Uterus size & position ·
d. Lab
Investigations - ·
CBC ·
Sugar (F/PP) ·
Vaginal pH ·
Urine (Routine and Microscopic). ·
USG, Pap smear (if needed). D. Inclusion Criteria : ·
Patient
willing to participate in the study with proper written consent. ·
Patient
ready to abstinence. ·
Patient
fulfilling cardinal symptoms of garbhashaya-yoni bharmsha. ·
Patient
having cystocele , rectocele , 1°& 2° Uterine prolapse. ·
Multiparous
women. ·
Patient
aged between 35-60 years. E. Exclusion Criteria
: · Complete procidentia · Patient having vaginal infections. · Patient not willing for abstinence. ·
Patient
having systemic diseases like HTN, DM, Thyroid disorder with the present study. ·
Pregnant
and lactating women. ·
Patients
with OCPs and IUCDS. ·
Patient
with any pelvic pathology or malignancy of genital organs. F. Discontinuation Criteria
: ·
Patient
does not want to continue trial. ·
Patient
not willing for abstinence. ·
Aggravation
of complaints. ·
Any
other acute illness or complications. ASSESSMENT CRITERIA : Assessment will be done on the basis of
improvement in the sign and symptom for the purpose ·
Feeling
of something coming down per vaginum. ·
Backache
or dragging pain in the pelvic region. ·
Feeling
of heaviness in pelvic region ·
Pain
during movement ·
Pain
during change in posture ·
Vaginal
discharge ·
Associated Symptoms – ·
Burning
micturition ·
Painful
micturition ·
Increased
frequency of micturition ·
Constipation ·
Dyspareunia Gynaecological Examinations
: ·
a.
Inspection of Vulva – ·
Healthy
or Unhealthy ·
b. Per
Speculum Examination- ·
Cervical
congestion ·
Vaginal
discharges ·
Vaginal
wall laxity ·
c. Per Vaginal
Investigation - ·
Cervical tenderness ·
Uterus size & position ·
d. Lab
Investigations - ·
CBC ·
Sugar (F/PP) ·
Vaginal pH ·
Urine (Routine and Microscopic).
·
USG, Pap smear (if needed). Assessment
of total effect of Therapy : Based on the assessment of the sign and
symptoms, the total effect of therapy is
evaluated and grouped according to following criteria – Marked improvement : 75 to 100% relief in the syptoms. Moderate improvement
: 50-75% relief in the symptom. Mild Improvement
: 25-50% relief in the symptoms. Unchanged
: Less than 25% relief in the symptoms. Statistical
Analysis :
Appropriate statistical tools will be used for
assessment at the end of the trial
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