| CTRI Number |
CTRI/2017/10/010228 [Registered on: 27/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Ashwagandha Vati and Satvavajaya chikitsa in Pre Menstrual syndrome |
|
Scientific Title of Study
|
Clinical study on efficacy of Ashwagandha Vati and Satvavajaya chikitsa in the management of Chittodvega in Pre Menstrual Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrilata |
| Designation |
2nd Year PG Scholar |
| Affiliation |
SDM college of ayurveda & hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda & Hospital
BM Road Thanniruhalla Hassan
Sri Dharmasthala Manjunatheshwara
College of Ayurveda & Hospital
BM Road Thanniruhalla Hassan
08172-256 460
sdmcah@gmail.com
Hassan
KARNATAKA
573201
India |
| Phone |
8147309776 |
| Fax |
- |
| Email |
shrilata.mudipu52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunatha Adiga |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital BM Road Thanniruhalla Hassan |
| Address |
Department of Manasa Roga Sri Dharmasthala Manjunatheshwara
College of Ayurveda & Hospital
BM Road Thanniruhalla Hassan
Department of Manasa Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9035715798 |
| Fax |
- |
| Email |
adiga.manjunatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrilata |
| Designation |
2nd Year PG Scholar |
| Affiliation |
Dr. Narayana Prakash B |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda & Hospital
BM Road Thanniruhalla Hassan
Sri Dharmasthala Manjunatheshwara
College of Ayurveda & Hospital
BM Road Thanniruhalla Hassan
08172-256 460
sdmcah@gmail.com
Raichur
KARNATAKA
573201
India |
| Phone |
8147309776 |
| Fax |
- |
| Email |
shrilata.mudipu52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM Road Thanneeruhalla Hassan 573201 KARNARAKA 08172256460 |
|
|
Primary Sponsor
|
| Name |
SDM college of ayurveda Hasaan |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda & Hospital
BM Road Thanniruhalla Hassan-573201 Karnataka India |
| 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 Shrilata |
Shri Dharmasthala Manjunatheshwara college of Ayurveda, Hassan |
OPD No. 5
Department Of Kayachikitsa Specialty Mano vigyan evum Manasa roga
Shri Dharmasthala Manjunatheshwara college of Ayurveda BM Road Thanneeruhalla
Hassan-573201 India
Hassan
KARNATAKA |
8147309776
-
shrilata.mudipu52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan-573201 Karnataka 08172-256 460 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
CHITTODVEGA IN PREMENSTRUAL SYNDROME, (1) ICD-10 Condition: F39||Unspecified mood [affective] disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
- |
- |
| Intervention |
ASHWAGANDHA VATI AND SATVAVAJAYA CHIKITSA |
Ashwagandha Vati of 500mg given in a dose of 2 vati each morning and evening after food.
Satvavajaya chikitsa is done under 4 sessions for 20 to 30 minutes which contains goal oriented psychotherapy, relaxation, yoga and pranayama.
Total duration of therapy is about one hour per day for one month. |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female subjects with regular menstrual cycle since 3 months.
Age between16 to 40 years irrespective of socio economic state and in good medical health.
|
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating woman.
Symptoms exist less than three cycles.
Subjects having uncontrolled diabetes mellitus, hypertension and other systemic diseases.
Subjects suffering from other acute and chronic psychiatric illnesses
Subjects suffering from organic brain diseases.
Subjects under hormonal and psychiatric treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Marked affective lability (e.g., mood swings, feeling suddenly sad or tearful, or increased sensitivity to rejection)
2.Marked irritability or anger or increased intra personal conflicts 3.Marked depressed mood, feelings of hopelessness, self deprecating thoughts.
4.Marked anxiety, tension, and/or feeling of being keyed up or on edge. |
PMS daily rating scale at 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| subjective and objective parameters |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2016 |
| Date of Study Completion (India) |
03/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/01/2017 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. 1. Arjun Chand, Shrilata. Adaptability of Satvavajaya Chikitsa in Family Counselling. International Journal Of Psychosocial Research. ISSN 2320-6381. July 2015, Special issue. Page no.136-139
2. Shrilata et al. Ayurvedic management of premenstrual syndrome: A case study. Int. J. Res. Ayurveda Pharm.2017;8(Suppl 2):119-121
3. Shrilata et al. A review on adaptogenic activity of Ashwagandha (Withania somnifera): An Ayurvedic appraisal. J Pharm Sci Innov.2017; 6(5): 94-98. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study titled “Clinical Study on Efficacy of Ashwagandha Vati and Satvavajaya Chikitsa in the Management of Chittodvega in Pre Menstrual Syndromeâ€
is a open labelled single group exploratory clinical trial conducted in SDM College of Ayurveda and hospital, Hassan to evaluate the combined effect of Ashwagandha vati and Satvavajaya chikitsa in Chittodvega in PMS.
The whole work is explained under the sections- Introduction, Review of literature, Materials and methods, Observation and results, Discussion and
Conclusion.
Introduction contains small description about the disease, Ashwagandha, Satvavajaya chikitsa and need for the study. Review of literature is explained first four chapters. The first chapter discuss in detail about the physiology of menstruation, Pre Menstrual Syndrome and its
conventional management. The second chapter is about Chittodvega, its interpretation, and management in brief as per the authentic textual references. The
third chapter explains about the drug Ashwagandha, its morphology, pharmacology and chemical constituents. Fourth chapter deals with the details of Satvavajaya
chikitsa, its techniques, benefits and a brief description of modern psychotherapies.
Material and methods contains the method of selection of samples, inclusion criteria, exclusion criteria, assessment criteria, intervention used, scale used and statistical tests used. 300 subjects were screened, 35 patients fulfilling the diagnostic criteria (ICD 10 N 94.3& DSM IV625.4) out of 191 subjects were selected within the age of 16-40 years. Subjects with systemic diseases, who are under medication, those having organic brain disorder or psychiatric diseases were excluded. The registered subjects were intervened with Ashwagandha vati 500mg twice daily with milk and Satvavajaya chikitsa for duration of 30 days. Satvavajaya chikitsa is defined under three titles Counseling, yoga & Pranayama and relaxation in specified schedule.
Counseling was done in divided sessions by setting a goal in every session. Methods used were classical and strategies, techniques used in CBT. Yoga advised were
Makarasana, Vajrasana and Shavasana. Pranayama technique selected was Nadishuddhi. The method of relaxation used here was toe to head progressive
muscular relaxation, which was taught to the patient. The follow up was done during luteal phase of next cycle i.e., approximately 28th day and 56th day from the
commencement of treatment.
Assessment was done by using Moos Menstrual Distress Questionnaire, before treatment, after treatment (28-30 days of commencement of treatment) and in follow
up (56-60th day of commencement of treatment).
Observation and results is the section which explains the frequency of demographic data, frequency of symptoms, statistical test results and their tabular representations.
Demographic data includes age, education, marital history, personal history etc. and frequency of symptoms shows the statistics of symptoms in percentage and number.
Most registered were 21- 25 years 63% (22), hindus 83% (29), of upper middle class socio economic status 52% (18) students 94% (33) and were unmarried 74% (26).
Menstrual history showed prevalence of menarche at the age of 13 years 46%(16) with 5 days of menstrual bleeding in 43%(15) having 28 days of interval between 2 cycles in 49%(17) without dysmenorrhea/clots/smell in 92% And Aggravation of symptoms on menstruation was absent in 97%(34). Personal history depicted mixed diet in 66%(23) having dominancy of katu rasa 57%(20), with dietetic habit vishamashana 54%(19). 97%(34) Subjects with irregular in exercise. Pareeksha showed prevalence of vata pitta prakruthi 43%(15), with rajasika manasa prakrithi
74%(26) having vishama agni &madhyama koshta 63%(22) with madhyama shareera bala 74%(26) and avara satva 66%(23). Prevalence of symptoms were 90% in Mood swings, anxiety, loneliness, crying, irritability, tension restlessness of registered subjects. Feeling sad, confusion, distractibility, difficulty concentration, abdomen
bloating, fatigue, backache, poor school or work performance was present in 80% of the subjects. Decreased efficiency, avoid social activity; feeling of suffocation was present in 70% of the subjects. All domain showed statistically significant result P<0.001 except Pain domain.
Discussion section contains discussion regarding the study from selection of topic to interpretation of diseases. Here possible interpretation is given to each part of
study and in every finding based on logic from basic principles of Ayurveda and authentic scientific articles. Justification regarding the selection of Ashwagandha,
with milk as anupana and Satvavajaya as supportive therapy is given here. The effect of the combined therapy may be due to the anxiolytic and Adaptogenic action of
Ashwagandha, nootropic and relaxation response effect of Satvavajaya chikitsa. The combined effect might have acted at biochemical level as well as biophysical level
there by alleviating the symptoms of Chittodvega in Pre Menstrual syndrome.
Conclusion contains the brief conclusion of results, the lacunae of the study, suggestion and scope for future researches.
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