| CTRI Number |
CTRI/2023/03/050768 [Registered on: 16/03/2023] Trial Registered Prospectively |
| Last Modified On: |
15/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Drakshadi avaleha in Anemia in pregnancy |
|
Scientific Title of Study
|
Randomized open controlled clinical trial to evaluate the add on effect of Drakshadi avaleha to reduce the symptoms of garbhini pandu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amruta Suryakant Bhakare |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic College kodoli |
| Address |
OPD No 8 Stree rog Prasuti tantra OPD Yashwant Charitable Hospital kodoli tal panhala dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7498584480 |
| Fax |
|
| Email |
bhakareamruta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita C Mule |
| Designation |
Asso Professor |
| Affiliation |
Yashwant ayurvedic College kodoli |
| Address |
Second floor department of stree rog Prasuti tantra Yashwant Charitable Hospital kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277612 |
| Fax |
|
| Email |
kvt126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Suryakant Bhakare |
| Designation |
GP scholar |
| Affiliation |
Yashwant ayurvedic College kodoli |
| Address |
OPD No 8 Stree rog Prasuti tantra OPD Yashwant Charitable Hospital kodoli tal panhala dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7498584480 |
| Fax |
|
| Email |
bhakareamruta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic College kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Amruta Suryakant Bhakare |
| Address |
OPD No 8 Stree rog Prasuti tantra OPD Yashwant ayurvedic hospital kodoli |
| 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 Amruta Suryakant Bhakare |
Yashwant Charitable Hospital |
OPD NO 8 Stree rog Prasuti tantra ground floor Yashwant Charitable Hospital kodoli Tal Panhala
Kolhapur
MAHARASHTRA |
7498584480
bhakareamruta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O990||Anemia complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Ferrous ascorbate | 100mg/day for 3 months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshadi avaleha, Reference: Harit samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Garbhini willingly participating in the trial and giving consent.
Garbhini having symptoms of Pandu will be taken for study.
Garbhini having Hb 8gm% to 10gm%
Garbhini having symptoms of pandurog.
12 to 36 weeks of pregnancy.
|
|
| ExclusionCriteria |
| Details |
Having known case of anaemia before pregnancy.
Hb below 8gm%
Anaemia associated with any other bleeding disorder such as
Haemorrhage, APH, Hookworm infection, Placenta previa,
Abruptio placenta etc.
Having known case of Thalassemia, Sickle cell anaemia, other hemoglobinopathies,Hereditaryhaemolyticanaemia.
Having known case Diabetes Mellitus.
Having known case Gestational Diabetes Mellitus.
Having known case Pregnancy induced hypertension or
any other medical illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the add on effect of Drakshadi Avaleha in garbhini pandu on assessment of objective parameter like Hb and subjective parameters like panduta agnimandya daurbalya arohan ayas |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the signs and symptoms of pandu in garbhini
To study the garbhini pandu in detail according to ayurveda & anaemia in
Pregnancy in detail according to modern text
|
120 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/04/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is randomised open control clinical trial of add on effect of Drakshadi avaleha to reduce the symptoms of garbhini pandu observation will be made upon symptoms of garbhini pandu study will be carried out in OPD of Stree rog department of Yashwant Charitable Hospital kodoli |