| CTRI Number |
CTRI/2024/04/066288 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Bala taila Snehana and Dashmula kwatha Swedana in lowering high blood pressure in women with PIH after delivery |
|
Scientific Title of Study
|
Randomized open controlled clinical trial of Bala taila sarvanga snehana and Dashmoola kwath nadi swedana as add-on effect in reducing the persistent high post-partum systolic and diastolic blood pressure in PIH cases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tinku Ganesh Prabhu Khalache |
| Designation |
Associate Professor department of Strirog-Prasutitantra |
| Affiliation |
Yashwant Ayurvedic College, Kodoli |
| Address |
Hon. Shri Annasaheb Dange Ayurved Medical College, A/p Ashta, Tal. Walwa, Dist. Sangli-
A/p Kodoli, Tal. Panhala, Dist. Kolhapur
Kolhapur
MAHARASHTRA
416113
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Vishala |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurved Mahavidyalaya, Kodoli |
| Address |
Department of Prasuti Tantra, Yashwant Ayurved Mahavidyalaya,Kodoli, Panhala, Kolhapur
A/p Kodoli, Tal. Panhala, Dist. Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Vishala |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurved Mahavidyalaya, Kodoli |
| Address |
Department of Strirog-Prasutitantra
Yashwant Ayurved Mahavidyalaya,Kodoli, Panhala, Kolhapur
A/p Kodoli, Tal. Panhala, Dist. Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College, Koldoli, Dist. Kolhapur-416114 (Maharashtra, India) |
|
|
Primary Sponsor
|
| Name |
Yashwant Ayurvedic College Kodoli Dist Kolhapur |
| Address |
A/p Kodoli, Tal. Panhala, Dist. Kolhapur - 416114 (Maharashtra;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 TinkuGanesh Khalache |
Yashwant Dharmartha Rugnalaya, Kodoli |
Department of Strirog-Prasutitantra, Yashwant Dharmartha Rugnalaya A/p,Kodoli, Tal.Panhala,Dist. Kolhapur-416114 (Maharashtra,India)
Kolhapur
MAHARASHTRA |
9423041730
tinkuganeshkhalache@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yashwant Ayurved Mahavidyalaya Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O265||Maternal hypotension syndrome. Ayurveda Condition: SUTIKAROGAH, (2) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. Ayurveda Condition: SUTIKAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Antihypertensive drug | Tab.Labetolol 100 mg BID for 7 days after food | | 2 | Intervention Arm | Procedure | - | Snehana and Swedana | (Procedure Reference: Ashtang Hruday, Procedure details: Snehana with bala taila & nadi sweda with dashmoola kwath)
(1) Medicine Name: Bala taila and Dashmoola Kwath, Reference: Ashtang Hruday, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.All Postpartum PIH cases irrespective of Age, Religion, Caste, Occupation and Socio-economic condition.
2. All Postpartum PIH cases undergone normal delivery or LSCS.
3. All Postpartum PIH cases with persistent systolic blood pressure of 140 to 180 mm Hg. and diastolic blood pressure of 90-100 mm Hg. |
|
| ExclusionCriteria |
| Details |
1.Any other Known systemic cardiovascular disease.
2. Postpartum cases with fever and skin infection.
3. Postpartum cases with systolic blood pressure of
more than 180 and diastolic of more than 100 mm Hg |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce high blood presure |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease complications due to PIH |
7 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/05/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pregnancy is very pivotal period for a woman as many physiological changes takes place during this period in her body. Hypertension is a common medical problem during pregnancy which is known as PIH. PIH is complicating pregnancy that contributes significantly to maternal and perinatal morbidity and mortality. There is no direct reference in Ayurvedic literature references regarding PIH but references regarding garbhini shotha and garbhini akshepaka has been explained in Kashyapa samhita. Garbhajanya Vishamayata (PIH) is the major medical problem encountered pregnancy. Hence this study is selected for research. |