| CTRI Number |
CTRI/2020/04/024953 [Registered on: 30/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enema in Irregular Menstrual Cycles |
|
Scientific Title of Study
|
A Randomised Controlled Clinical study to evaluate the efficacy of Arkapushpa taila matra basti in the management of Artava Kshaya with special reference to Oligomenorrhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavitra |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
PTSR Class room, Second floor, Department of PG Studies in Prasooti Tantra and Stree roga, Sri Sri College of Ayurvedic Science & Research 21st KM Kanakapura road PO Udayapura Bangalore
Bijapur
KARNATAKA
560082
India |
| Phone |
8951382785 |
| Fax |
|
| Email |
pavitrabmanaguli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharon Samuel |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Faculty, Department of PG Studies in Prasooti Tantra and Stree Roga. Sri Sri College of Ayurvedic Science & Research 21st KM Kanakapura road PO Udayapura Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9884832050 |
| Fax |
|
| Email |
sharon.avp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavitra |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
PTSR Class room, Department of PG Studies in Prasuti Tantra and Stree Roga, Sri Sri College of Ayurvedic Science & Research 21st KM Kanakapura road PO Udayapura Bangalore
Bijapur
KARNATAKA
560082
India |
| Phone |
8951382785 |
| Fax |
|
| Email |
pavitrabmanaguli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science and Research Hospital Bengaluru Karnataka-560082 |
|
|
Primary Sponsor
|
| Name |
Dr Pavitra B |
| Address |
Sri Sri College Of Ayurvedic Science and Research Hospital Bengaluru, Karnataka- 560082 |
| Type of Sponsor |
Other [Self] |
|
|
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 Pavitra B |
Sri Sri College of Ayurvedic Science and Research Hospital |
Room no 10. OPD of Prasuti Tantra and Stree roga, Sri Sri College of Ayurvedic Science and Research Hospital, 21st km, Udayapura post, Kanakapura road, Bangalore-82
Bangalore
KARNATAKA |
8951382785
pavitrabmanaguli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N915||Oligomenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arka pushpa taila matra basti |
dose - 1.5 pala (70ml)
frequency- Once a day/ 7 days route of administration - Rectal duration of therapy - 7 days |
| Comparator Agent |
Shatapushpa taila matra basti |
dose - 1.5 pala (70ml)
frequency- Once a day/ 7 days route of administration - Rectal duration of therapy - 7 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
- Subjects age between 21 to 35 years
- Subjects presenting the classical symptoms
- subjects presenting with symptoms of oligomenorrhea
- spotting/ bleeding less than 2 days
- Both married and unmarried
- subjects willing for Basti karma
|
|
| ExclusionCriteria |
| Details |
- Pregnant women
- Lactating women
- Haemoglobin less than 8 gm%
- Subjects with other systemic illness
- Subjects with any ano-rectal complaints
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Number of pads used per day
2)Duration of menstrual cycle
Grading
Duration of menstrual cycle
Grade 0 4-7 days
Grade 1 3-4 days
Grade 2 2-3 days
Grade 3 1-2 days
Number of pads used per day
Grade 0 - 3-4 pads/day
Grade 1 - 2-3 pads/day
Grade 2 - 1-2 pads/day
Grade 3 - Spotting |
31st day adn 60th day of study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Interval between two cycles
Grade 0 - 28-32 days
Grade 1 - 32-36 days
Grade 2 - 37-41 days
Grade 3 - 41 days
2) Pain during menstruation (yoni vedana)
Grade 0 - No pain
Grade 1 - Mild pain
Grade 2 - Moderate pain
Grade 3 - Severe pain
|
31st day, and 60th day of study period |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| 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="7"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
study under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Woman’s health is the primary factor to be considered for wellbeing of family, society and culture. Any physical,
physiological disorder disturbs the woman’s
life. Physiological changes and development occur from birth but
markedly during reproductive period. Stress and change in lifestyle leads to
many gynaecological problems. Among all the Gynaecological problems, the most
common one is menstrual irregularities i.e. in the form of ar- tava kshaya.
Artava kshaya is that condition in which menstruation fails to occur at
appropriate time (delayed) with scanty flow and does not last for 3 days.
A similar entity in modern classics where menstrual
bleeding occurs more than 35days apart and which remains constant at that
frequency is called Oligomenorrhea.
About 30% women in their
reproductive life suffer from irregular periods. Among these menstrual
irregularities
Oligomenorrhea accounts to 18.3%.
The treatment opted in modern system of medicine is
Hormonal therapy, which may have adverse effect on body like obesity, nausea,
vomiting, endometrial cancer and breast cancer.
So, to prevent these
hazards and to maintain healthy life, safe ayurvedic non-hormonal therapy is
required. In this regard, the treatment principle explained by Kashyapa for Artava kshaya is taken for study.
He considers it as an Anuvasana
sadhya vyadhi. Matra basti is a type of Anuvasana
basti in which the quantity of Sneha for
Matra basti is 1/4th of Sneha basti. It can be given at any time without any strict
restriction on diet and activity. Arkapushpa taila is artavapravartaka,laghu in guna,
has ushnavirya and katuvipaka. Thus, taking the treatment principle into consideration an agneya dravya i.e.
Arkapushpa taila is chosen for Matra basti in Artava kshaya.
OBJECTIVES OF THE STUDY:
•
To evaluate the effect of Arkapushpa taila matra basti in the
management of Artava kshaya.
•
To evaluate the effect of Shatapushpataila matra basti in the
management of Artava kshaya.
•
To compare the efficacy of Arkapushpa
taila and Shatapushpa taila matra basti
in the management of Artava kshaya.
|