| CTRI Number |
CTRI/2023/11/059884 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
07/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE
EFFECT OF CHINNARUHADI KSHEERAPAKA & ASHWAGANDHADI
KSHEERAPAKA IN 6th AND 7
th MONTH OF PREGNANCY |
|
Scientific Title of Study
|
A randomised comparative clinical study to evaluate the effect of Chinnaruhadi ksheerapaka and ashwagandhadhi ksheerapaka in 6th and 7th month of pregnancy |
| 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 Meghashree B |
| Designation |
PG scholar |
| Affiliation |
Rajiv Gandhi University |
| Address |
OPD 1
Department of Prasooti Tantra and Streeroga
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Udupi
Udupi
KARNATAKA
575006
India |
| Phone |
8971027950 |
| Fax |
|
| Email |
meghashreeyadav261@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meghashree B |
| Designation |
Pg scholar |
| Affiliation |
Rajiv Gandhi University |
| Address |
OPD 1
Department of Prasooti Tantra and Streeroga
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Udupi
Udupi
KARNATAKA
575006
India |
| Phone |
08971027950 |
| Fax |
|
| Email |
meghashreeyadav261@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramadevi G |
| Designation |
Professor HOD |
| Affiliation |
Rajiv Gandhi University |
| Address |
OPD 1
Department of Prasooti Tantra and Streeroga
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9449937158 |
| Fax |
|
| Email |
dr.ramadevig@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala manjunatheshwara college of ayurveda Kuthpadi Udupi |
|
|
Primary Sponsor
|
| Name |
Shri Dharmasthala manjunatheshwara |
| Address |
Shri Dharmasthala manjunatheshwara college of ayurveda Udupi Karnataka 574118 |
| Type of Sponsor |
Private medical college |
|
|
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 meghashree b |
Shri Dharmasthala Manjunatheshwara college of Ayurveda Udupi |
OPD 1
Department of Prasooti Tantra and Streeroga
Udupi
KARNATAKA |
08971027950
meghashreeyadav261@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| lnstitutional Ethical Committee Shri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O269||Pregnancy related conditions, unspecified. Ayurveda Condition: GARBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chinnaruhadi ksheerapaka , Reference: Ashtanga Sangraha Shareera Sthana 3rd chapter 7-8th sloka , Route: Oral, Dosage Form: Ksheerpaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Ashwagandhadhi ksheerapaka , Reference: Ashtanga Hridaya Shareera Sthana 3rd Chapter 7-8th sloka, Route: Oral, Dosage Form: Ksheerpaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primi and multi gravida
1.Subjects limited to the age group of 20-35 years.
2.pregnant women of 21 -27 weeks gestation age |
|
| ExclusionCriteria |
| Details |
1.Disease like chronic diarrhoea, chronic dysentery.
2.Pregnancy complicated by anaemia, Multiple Pregnancy, APH, GDM, PIH, pre-
eclampsia, Eclampsia, co-existing fibroid, Thyroid disfunction, Hyperemesis
gravidarum.
3.Diagnosed cases of IUGR, Oligohydramnios, Polyhydramnios
4.Systemic diseases such as Hypertension, Cardiac diseases, Diabetic mellitus, HIV,
Bronchial asthma, Hepatitis B etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increased fetal and maternal weight
Fetal well being
Normal total protein and globulin count |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Normal total protein and globulin count |
2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/11/2023 |
| 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="0"
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
|
- In 6th month of pregnancy there will be bala varnopachaya of fetus which brings about
balavarna hani in mother . - In 7th month, overall maturity of the foetus occurs causing excessive exhaustion in mother.
- To overcome these changes in the pregnant mother, acharyas have mentioned various forms of ksheerapaka in the context of masanumasika paricharya
- Ksheera is mentioned as Garbhaposhana, jeevaniya, rasayana, balya, shramahara.
- The drug combination selected for the study i.e., guduchi, shathavari, bala, vidarikanda,
gokshura,aswagandha,gambhari,sariva, yashtimadhu, punarnava has balya, rasayana and
garbhasthapana properties - These drugs will be effective in fulfilling the nutritional demands of garbhini and sustaining pregnancy.
- Hence keeping all the above points in the back drop, in order to ensure a successful pregnancy with positive maternal and foetal outcome and also to prevent the common ailments during pregnancy, Chinnaruhadi ksheerapaka & Ashwagandhadi ksheerapaka has been taken for the study.
- The clinical study is supported by assessing maternal and fetal weight along with maternal total protein count before and after treatment.
|