| CTRI Number |
CTRI/2018/02/012121 [Registered on: 23/02/2018] Trial Registered Prospectively |
| Last Modified On: |
11/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sai Vibrionics and Primordial Sound Chanting] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study the effect of two health and wellness therapies during and after pregnancy |
|
Scientific Title of Study
|
ANIRVID: A multi-center study to evaluate
the effect of complimentary alternative interventions on perinatal depression and its
associated heart and thyroid function using conventional techniques, metabolomics
and point of care device. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
Sri Sathya Sai Institute of Higher Learning
Prasanthi Nilayam campus, Puttaparthi, Anantapur District
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
Sri Sathya Sai Institute of Higher Learning
Prasanthi Nilayam campus, Puttaparthi, Anantapur District
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
Sri Sathya Sai Institute of Higher Learning
Prasanthi Nilayam campus, Puttaparthi, Anantapur District
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
|
Source of Monetary or Material Support
|
| Tata Education and Development Trust
c/o. Sri Ratan Tata Trust, Bombay House, Homi Mody Street, Fort, Mumbai 400001
Tel.: 022-66658282 |
|
|
Primary Sponsor
|
| Name |
Tata Education and Development Trust |
| Address |
c/o. Sri Ratan Tata Trust, Bombay House, Homi Mody Street, Fort, Mumbai 400001
Tel.: 022-6665 8282 Fax: 022-6665 8013 |
| Type of Sponsor |
Other [Private Funding Agency] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madras Loukya |
Sri Sathya Sai General Hospital |
Room No. 6, Ground
Floor, Department of
Obstetrics and
Gynaecology, Prasanthi
Nilayam,
Puttaparthi-515134
Anantapur
ANDHRA PRADESH |
8374777665
drloukya@gmail.com |
| Dr Akkamahadevi C Hiremath |
Sri Sathya Sai General Hospital, Sri Sathya Sai Institute of Higher Medical Sciences |
Room No. G918,
Ground Floor,
Department of
Obstetrics and
Gynaecology, EPIP
Area, Whitefield,
Bangalore-560066
Bangalore
KARNATAKA |
9448434567
akkuch@yahoo.co.in |
| Dr Gautam Rege |
Sri Sathya Sai Institute of Higher Medical Sciences |
Department of Cardiology, SSSIHMS, Prasanthi Gram, Puttaparthi 515134
Anantapur
ANDHRA PRADESH |
9890787417
gautam.rege@sssihms.org.in |
| Dr Srikanth Sola |
Sri Sathya Sai Institute of Higher Medical Sciences |
Department of Cardiology, SSSIHMS,EPIP Area, Whitefield, Bangalore - 560 066
Bangalore
KARNATAKA |
9986827319
srikanth.sola@sssihms.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Learning |
Approved |
| Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Learning |
Approved |
| Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Learning |
Approved |
| Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Learning |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Depression and its related thyroid and heart function, during and after pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
No placebo and no complementary alternative interventions. Only standard care of treatment |
| Comparator Agent |
Placebo |
Dosage: QDS for 1 month then TDS till delivery; after delivery TDS for 6-8
weeks.
Dose: 1 sugar pill of size 30 without infusing with Subtle vibrations
Above dose and dosage is in addition to standard care of treatment |
| Intervention |
Primordial Sound Chanting |
Chant daily twice till 6-8 weeks after delivery. 10 mins in the mornings and 10 mins in the evenings.
In addition to standard care of treatment above chanting regime will be administered |
| Intervention |
Sai Vibrionics (Placebo with subtle vibrations) |
Dosage: QDS for 1 month then TDS till delivery; after delivery TDS for 6-8
weeks.
Dose: 1 sugar pill of size 30 infused with subtle Vibrations
Above dose and dosage is in addition to standard care of treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant Women in the age: ≥18 years and ≤40 years |
|
| ExclusionCriteria |
| Details |
Pregnant women who are already on psychotropic medication; and Pregnant women who are already taking any complementary and alternative interventions |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Biomarker based point-of-care device to monitor perinatal depression, cardiac and thyroid functions, mainly in resource limited settings
Use of simple, effective, drug-free and cost-effective complementary and alternative medicine for pregnant women |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will facilitate the early diagnosis and management of depression and its related disorders in pregnant women and mothers |
3 years |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "348"
Final Enrollment numbers achieved (India)="348" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2018 |
| Date of Study Completion (India) |
24/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
3 publications
1. 1. Badiya,P.K. et al., Effect of mode of administration on Edinburgh Postnatal Depression Scale in the South Indian population: A comparative study on self-administered and interviewer-administered scores. 66, 102890. 2021 October 21. Asian Journal of Psychiatry.
2. Badiya, P.K. et al., Task-sharing to screen perinatal depression in resource limited setting in India: Comparison of outcomes based on screening by non-expert and expert rater. 62, 102738. 2021 Aug 1. Asian Journal of Psychiatry.
3. Badiya, P.K. et al., Identification of clinical and psychosocial characteristics associated with perinatal depression in the south Indian population. 66, 161-170. 2020 Sep 1. General Hospital Psychiatry. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Perinatal depression is highly prevalent and is
a major public health issue as it affects both the mother and the newborn. In
addition, several study findings implicate depression as one of the causative
factors for cardiovascular disease and thyroid disorders. Therefore, early
detection of depression is necessary for the benefit of both mother and child.
The main goal of this proposed multi-center study is to develop a more rapid,
hand-held, mobile-health point-of-care (POC) diagnostic device - ‘Anirvid’ for
monitoring key biomarkers related to perinatal depression and its related
disorders at low-cost than current existing systems. In addition, the efficacy
of drugs-free complementary and alternative interventions on perinatal depression
and its associated cardiac and thyroid functions will also be studied using
‘Sai Vibrionics’ and ‘Primordial Chanting.’ Therefore, the proposed study will
facilitate early diagnosis, prognosis and modification in the management of
perinatal depression for the benefit of pregnant women and mothers in the
society. |