| CTRI Number |
CTRI/2019/08/020493 [Registered on: 01/08/2019] Trial Registered Prospectively |
| Last Modified On: |
31/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Raktamarisha Ghana vati (An anubhuta yoga) in Garbhini Pandu. |
|
Scientific Title of Study
|
An open labelled single arm clinical study of Raktamarisha Ghana vati in 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 |
Bhakti Bhagwanrao Kharat |
| Designation |
1st year Pg scholar |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya, Malwadi, Hadapsar. |
| Address |
Rishi-Prasad niwas,nutan vasahat,ambad.tq- ambad
Dist- jalna
Sane Guruji Hospital ,Hadapsar Pune, Maharashtra.
Pune
MAHARASHTRA
431 204
India |
| Phone |
8275931464 |
| Fax |
|
| Email |
bhaktikharat7070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Manda Sanjiv Ghorpade |
| Designation |
HOD Of striroga and Prasutitantra. |
| Affiliation |
Maharashtra Arogya Mandal. |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya,OPD no. 12,Department of Striroga and Prasutantra,Sane Guruji Arogya kendra,Malwadi, Hadapsar,Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007570 |
| Fax |
|
| Email |
mandaghorpade@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Manda Sanjiv Ghorpade |
| Designation |
HOD Of Striroga and Prasutitatra. |
| Affiliation |
Maharashtra Arogya Mandal. |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya,OPD no. 12,Department of Striroga and Prasutantra,Sane Guruji Arogya kendra,Malwadi, Hadapsar,Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007570 |
| Fax |
|
| Email |
mandaghorpade@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bhakti kaharat, Department of string and Prasutitantra, Sane Guruji arogya Kendra, Hadapsar, Pune. |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
OPD no 12,Sane Guruji arogya Kendra ,malwadi,Hadapsar , Pune Maharashtra. 411028. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bhakti Bhagwanrao Kharat |
OPD no 12, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune,Maharashtra. 411028 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manda S Ghorapade |
Striroga and Prasutitantra dept no 12. |
Sane Guruji arogya Kendra Malwadi, Hadapsar.
Pune
MAHARASHTRA |
9822007570
mandaghorpade@yahoo.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: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Raktamarisha Ghana Vati (An Anubhuta yoga) |
Drug- Raktamarisha GHana Vati will be prepared by making kwatha kalpana from Raktamarisha and ghana will be obtained after boiling kwatha and vati of 500mg will be prepared
dose- 500mg TDS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Hb below 10% and above 7%
2.All Garbhini patients fulfilling diagnostic criteria of Pandu.
3.Iron deficiency anaemia, microcytic Hypochromic anaemia, microcytic Normochromic Anemia.
3.2nd and 3 rd trimester patients.
|
|
| ExclusionCriteria |
| Details |
1.Multiple pregnancy.
2.Bad Obstetrics history and precious pregnancy.
3.Drug allergy.
4.Haemoglobinopathies like thalassemia, sickle cell anemia, pernicious anemia etc
Anemia associated with the haemorrhagic disorders.
5.High risk pregnancy.
6.Secondary anaemia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Raktamarisha Ghana vati (An anubhuta yoga) in Garbhini Pandu.
Efficiency of Raktamarisha as a Pathya in pregnancy.
Healthy baby with Healthy mother. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Literary review of Raktamarisha will b carried out.
Complications due to Anaemia will reduce.
|
2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
02/09/2019 |
| 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="2"
Days="2" |
|
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)?
|
|
Brief Summary
|
The study is Open labelled single arm clinical study of RAKTAMARISHA GHANA VATI (an Anubhuta yoga) in Garbhini Pandu. Total 50 Patients will be selected by calculating prevalence rate for the study for duration of 2 months. Effect of Drug will be studied and conclusion will be drawn according to observations and results. Nowadays anaemia is a very common in pregnancy and it’s a life threatening disease. During pregnancy it can cause Preterm Labour pains, Abruptio placentae, Intrauterine growth Restriction, Low birth weight Baby. In puerperium it causes PPH, sepsis, delayed in wound healing of episiotomy and LSCS surgical wound. RAKTAMARISHA means AMARANTH is a highly nutritious vegetable also proven Nutraceuticals rich in Iron, folic acid, vit C, and other micronutrients. Raktamarish is Raktapittahara according to Bhavaprakash. So extract of this will be taken out by making Ghana and Vati will be prepared to make easy to take and will be helpful for the patients who don’t like to eat vegetables. Line of treatment for Anemia is Iron supplements, Some patients shows intolerance , Nausea, Vommitting , Gastric Disturbance to Avoid this obstetrician advice RAKTAMARISHA means in Marathi Laalmath as a Pathya dravya, so study will be conduct to see the efficacy and adverse effects or RAKTAMARISHA in Garbhini Pandu. Raktamarisha is a very cheap and easily available. |