| CTRI Number |
CTRI/2021/01/030772 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
25/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment in polycystic ovary syndrome |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY ON VATA KAPHAJA ARTAVADUSHTI POLY CYSTIC OVARY SYNDROME AND ITS MANAGEMENT BY LASHUNA CAPSULES AND SHATAPUSHPA TAILA MATRABASTI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asokan V |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 309 Dept of PTSR
PIA PU
Parul University
Limda
Vaghodia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9008838531 |
| Fax |
|
| Email |
drasokan24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asokan V |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 309 Dept of PTSR
PIA PU
Parul University
Limda
Vaghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9008838531 |
| Fax |
|
| Email |
drasokan24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhagyashree Purna satpathy |
| Designation |
PG scholar |
| Affiliation |
Parul University |
| Address |
Room No 104 OPD of Dept of PTSR
Teaching hospital of Parul Institute Of Ayurveda
Limda
Vaghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9348062527 |
| Fax |
02668-260201 |
| Email |
satpathybhagyashree92@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PIA |
| Address |
Faculty of Ayurveda Parul University
Limda
Vaghodia
Vadodara |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhagyashree Purna Satpathy |
Teaching Hospital of Parul Institute of Ayurveda |
OPD 104
Dept of PTSR
Parul University
Vadodara
GUJARAT |
9348062527
02668-260201
satpathybhagyashree92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: GRANTHIBUTA-ARTAVADUSHTIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Matrabasti with oral medication |
1 Lashuna capsule Lashuna capsule 500mg 2 times per day after meals for 2 months
2 Shatapushpa taila matrabasti with Shatapushpa taila 60ml for7 days daily afternoon after meals following cessation of menses in 2 consecutive cycle
|
| Intervention |
oral medication
Lashuna capsule |
1 Lashuna capsule Lashuna capsule 500mg 2 times day after meals for 2 months on 30 patients
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Women aged as specified above irrespective of marital status
2 Clinical features of PCOS like Oligomenorrhoea Anovulation Anovulatory Infertiliy Acne Hirsutism Obesity Acanthosis nigricans
3 Patient Presenting with VataKaphaja Artavadushti Nastartava Yathochitkaladarshanam Alpamatra Yonivedana Artavanasha
4 Diagnostic criteria Rotterdam revised criteria 2004 2 out of 3 symptoms if present
a Oligo and or anovulation
b Hyperandrogenism 1 Clinical Acne Hirsutism
2 Biochemical S Testosterone more than 70 ng per m
PCOS features on USG more than 12 Follicles of 2 to 9mm in size in each ovary or Ovarian volume more than 10 cc |
|
| ExclusionCriteria |
| Details |
1 Patients having age group Less than 18 yrs and more than 40 yrs
2 Patients having menorrhagia or metrorrhagia
3 Patients with any other Systemic illness like Patients suffering from uncontrolled hypertension Hepatic or Renal disease Cushings syndrome Cardiac diseases diabetes mellitus tuberculosis psychological disorders
4 Organic lesions of reproductive tract like Carcinoma and congenital deformities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To compare and evaluate the clinical efficacy of Lashuna Capsule and Shatpushpa Taila Matrabasti on reduction of cyst and decreasing ovarian volume and inducing ovulation
2 To compare and evaluate the clinical efficacy of Lashuna Capsule and Shatpushpa Taila Matrabasti in regularization of menstrual cycle
|
60 days
Follow up after 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To review the literature in Vata Kaphaj Artavadushti with special reference to PCOS and review the literature in Lashuna Capsule and Shatapushpa Taila Matrabasti and its therapeutic evaluation in the management of Artavadushti PCOS
|
6 months |
|
|
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 1 |
|
Date of First Enrollment (India)
|
01/02/2021 |
| 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
|
will be done after the completion of trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION
In Vata-Kaphajaa
Artavdushti (Granthibhuta), caused by Dushti
of Vata and Shleshma and associated with
other features of both the Doshas. When
Artava Vahini Sira get obstructed by Prakupita Vata and Kapha ,passage of Artava
carrying channel is obstructed. So Artava
is not apparent monthly, which results in amenorrhea (nashtartava)3 it
results in Nashtaartava. In Artavavahasrotas Viddha Lakshana also ,Artavanasha
(Secondary Amenorrhea) is absorbed.5 Therefore the above
symptoms can be correlated with the symptoms of Poly Cystic Ovary Syndrome
(PCOS).
Need
of the study-
PCOS is a
common female endocrine disorder with prevalence ranging from 2.2% to 26%. In
Global ratio, 1 among 15 women have PCOS.Adolescent girls in schools have 9.13%
- 36%,Reproductive age- 30% ,Peri-menopausal women - 6-10%.Lashuna which is found to be useful in Pushpa( Artava )Rogas8
.The indication of Basti in Alpapushpa,Nashtapushpa,Nastabeeja,and Akarmanyabeeja which can be considered
as the symptoms of Artavadushti. 9
HYPOTHESIS:
Null
Hypothesis (H0):
Lashuna
Capsules alone or Lashuna Capsule along with Shatpushpa Taila
Matrabasti is not effective in the management of Vata - Kaphaja Artavadushti
(PCOS)
Alternate Hypothesis (H1):
Lashuna Capsules alone or Lashuna Capsule along with Shatapushpa Taila
Matrabasti is effective in the management of Vata-Kaphaja Artavadushti (PCOS)
RESEARCH
QUESTION:-
Is Lashuna
Capsule orally alone in a dose of
500mg B.D for 2 months in combination with Shatpushpa Taila Matrabasti in a
dose of 60 ml for 7 days in 2 consecutive menstural cycles is effective in
Vata-kaphaja Artavadushti (PCOS)INTRODUCTION
In Vata-Kaphajaa
Artavdushti (Granthibhuta), caused by Dushti
of Vata and Shleshma and associated with
other features of both the Doshas. When
Artava Vahini Sira get obstructed by Prakupita Vata and Kapha ,passage of Artava
carrying channel is obstructed. So Artava
is not apparent monthly, which results in amenorrhea (nashtartava)3 it
results in Nashtaartava. In Artavavahasrotas Viddha Lakshana also ,Artavanasha
(Secondary Amenorrhea) is absorbed.5 Therefore the above
symptoms can be correlated with the symptoms of Poly Cystic Ovary Syndrome
(PCOS).
Need
of the study-
PCOS is a
common female endocrine disorder with prevalence ranging from 2.2% to 26%. In
Global ratio, 1 among 15 women have PCOS.Adolescent girls in schools have 9.13%
- 36%,Reproductive age- 30% ,Peri-menopausal women - 6-10%.Lashuna which is found to be useful in Pushpa( Artava )Rogas8
.The indication of Basti in Alpapushpa,Nashtapushpa,Nastabeeja,and Akarmanyabeeja which can be considered
as the symptoms of Artavadushti. 9
HYPOTHESIS:
Null
Hypothesis (H0):
Lashuna
Capsules alone or Lashuna Capsule along with Shatpushpa Taila
Matrabasti is not effective in the management of Vata - Kaphaja Artavadushti
(PCOS)
Alternate Hypothesis (H1):
Lashuna Capsules alone or Lashuna Capsule along with Shatapushpa Taila
Matrabasti is effective in the management of Vata-Kaphaja Artavadushti (PCOS)
RESEARCH
QUESTION:-
Is Lashuna
Capsule orally alone in a dose of
500mg B.D for 2 months in combination with Shatpushpa Taila Matrabasti in a
dose of 60 ml for 7 days in 2 consecutive menstural cycles is effective in
Vata-kaphaja Artavadushti (PCOS) Assesment
criteria-
Subjective
–
➢ Menstural History
➢ Duration of Bleeding
➢ Interval
Between two
Menstrual Cycle
➢ Quantity
of Menstrual blood
➢ Pain During Menstrual Bleeding
OBJECTIVE PARAMETER
➢ Weight
➢ OVULATION (FOLLICULAR SIZE)
➢ HIRSUTISM
➢ ACNE
➢ ACANTHOSIS NIGRICANS ON NECK
ASSESMENT OF……………….
LABAROTARY INVESTIGATIONS-1.
Hematological examinations
like Hb%, R.B.S.,ESR.
2. U.S.G. Investigation
3. Serum testosterone level.
4. Other investigation
if necessary.(URM, FBS,k/c/o –Thyroid
dysfunction- T3,T4,TSH,
S.Cholestrol)
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