| CTRI Number |
CTRI/2024/01/062151 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the benefits of satavari ksheerapaka and ksheerabala siropichu in mild to moderate postpartum depression |
|
Scientific Title of Study
|
“An open label single arm clinical study to
evaluate the combined effect of internal administration of satavari kshirapaka and
kshirabala taila siropichu in mild to moderate post partum depression†|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dafini David |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda, |
| Address |
Department of striroga and Prasuti Tantra,Amrita School of Ayurveda,
Amrita Vishwa vidyapeetham,Amritapuri
Clappana P.O,Kerala,India,Kollam
Kerala
Kollam
KERALA
690525
India |
| Phone |
7598754975 |
| Fax |
|
| Email |
dafinidavid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaithya Raj |
| Designation |
Associate Professor,Department of Striroga and Prasuti Tantra (Gynecology and Obstetrics) |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham
Amritapuri,Clappana P.O,Kerala,India,Kollam
Kollam
KERALA
690525
India |
| Phone |
9495434862 |
| Fax |
|
| Email |
shaithyaraj@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dafini David |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of striroga and Prasuti Tantra,Amrita School of Ayurveda,
Amrita Vishwa vidyapeetham,Amritapuri
Clappana P.O,Kerala,India,Kollam
Kerala
Kollam
KERALA
690525
India |
| Phone |
7598754975 |
| Fax |
|
| Email |
dafinidavid@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham,Amritapuri
Clappana P.O,Kerala,India,Kollam
|
|
|
Primary Sponsor
|
| Name |
Dr Dafini David |
| Address |
Amrita School of Ayurveda,
Amrita Vishwa vidyapeetham,Amritapuri
Clappana P.O,Kerala,India,Kollam
|
| 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 Dafini |
Amrita Ayurveda Hospital |
OPD,Department of Striroga and Prasuti Tantra,
Department of Gynecology and Obstetrics
Amrita Vishwa Vidyapeetham
Amritapuri Campus,Clappana P.O,Kollam-690525 ,kerala, India
Kollam
KERALA |
07598754975
dafinidavid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O906||Postpartum mood disturbance. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Satavari Ksheerapaka, Reference: Raja Nighantu,Kashyapa Samhitha, Route: Oral, Dosage Form: Ksheerpaka, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | siro pichu | (Procedure Reference: Astanga Hridaya Sutarasthana, Procedure details: Śiropicu procedure will be explained in detail to the patient and advised to do Śiropicu with 10ml of Kṣīrabala taila (more the quantity patient may suffer from sinusitis & headache)1 hour before sleep with a duration of 30 minutes for 7 days and after the procedure wiped off with a dry cloth.
)
(1) Medicine Name: Ksheerabala Taila, Reference: Saharayoga Taila Prakarana, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(ml), Frequency: hs, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age between eighteen to fortyyears,
primi or multigravida without labour complications,
Epds score greater than 13,
hamitons score greater than eight and eighteen, patients from four weeks to tenmonths are included |
|
| ExclusionCriteria |
| Details |
EPDS score less than 13,
Hamiltons score greater than 18,
ICD10 diagnostic criteria with severe episodes are excluded,
Previous history of psychiatric disorder,
under antidepressent medications,
Active suicidal,homicidal and infanticide thoughts during prescreening. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in mild-moderate symptoms associated with Post- Partum Depression assessed by using EPDS Scale,HDRS-17 Scale and ICD-10 Diagnostic Criteria |
8th day and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
02/02/2024 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post-Partum Depression (PPD) is defined as a major depressive episode
in which symptoms can occur within a few months to a year after childbirth
and it is characterized by
insomnia, loss of appetite, anxiety and insecurity, emotional instability,
mental confusion, loss of self-confidence, and suicidal ideation. The clinical
presentations like pralÄpa, bhrama, prajÄgara, Å›oka ,kliá¹£á¹amana, viá¹£Äda,
anavasthitacittatvÄ , Agnimandhya can be visualized at different symptom
complexes in PPD and it is mentioned under sÅ«tikÄ rogas, vÄtaja
nÄnÄtmaja vikÄras and unmÄdaÅšatÄvarÄ« is considered as kalinaÅ›ini
dravyÄ it has smá¹›ti medÄ vardhaka & Bhuta Kalmasha Shapagni Properties
.It has medÄ dhÄraṇa Å›akti kÄraka, Rasayana, agni ojo &stanya
vardhana ,vÄtapitta hara action and it is considered as mahÄ Å›reá¹£á¹a
rasÄyana. Kṣīra
is indicated in pralÄpa, bhrama, prajÄgara and
it has rasÄyana & medhyÄ action
Kṣīrabala taila is indicated in 80 types of vÄta roga
hence its effect can be seen in viá¹£Äda ,pralÄpa ,asvapna ,anavasthitacittatvÄ
]which are the symptom complex experienced by Postpartum
depression women.30 patients who fulfil the inclusion criteria will be
selected from OPD and IPD Amrita Ayurveda Hospital. Written informed consent will be taken from patients and
detailed history of the patient will be taken with a case proforma. EPDS Questionnaire will be given to all the Post-Partum women who were taking consultation in hospital. The EPDS scores are being calculated. Women with EPDS score >13 will be enrolled in the study.
Written informed consent will be taken from patients and detailed history of the patient will be taken with a case proforma.
Baseline data, HDRS-17 score, ICD-10 scores are calculated to categorize in mild - moderate depression
and to exclude the high-risk
cases. Each patient is advised
for treatment with Kṣīrabala taila Śiropicu
for 7 days & Internal
administration of ÅšatÄvarÄ« kṣīrapÄka
for 30 days. Based on Astanga Sangraha Reference,ask the patient to prepare Ksheerapaka . First Kashaya of the drug will be prepared
and filtered. To that equal quantity of milk is added and boiled till the milk part remains .2 Pala (96 ml) of kṣīrapÄka is advised to take in an empty stomach for 30 days.Åširopicu procedure will be explained
in detail to the patient and advised to do Åširopicu 1 hour before sleep with a duration of 30 minutes
for 7 days and after the procedure
wiped off with a dry cloth.
Procedure will be continued for 7 days. First Post assessment will be done with EPDS on the day 8 after completing the Åširopicu . Second Post assessment
will be done after 30 days and the improvement in mild- moderate
symptoms will be evaluated through EPDS scale, HDRS-17 & ICD-10 diagnostic
criteria. Once the endpoint is reached, the patient is censored from the study. |