| CTRI Number |
CTRI/2025/03/081718 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical
Other (Specify) [Interventional] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of Garbhakshaya( Oligohydramnios) |
|
Scientific Title of Study
|
EFFECT OF KUSHMANDA GRANULES IN THE MANAGEMENT OF GARBHODAKA KSHAYA W.S.R TO OLIGOHYDRAMNIOS- A RANDOMIZED OPEN LABELLED STANDARD CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Kumari |
| Designation |
M.S Scholar |
| Affiliation |
Institue of Teaching and Research in ayurveda,INI, Jamnagar |
| Address |
Department of prasutitranta Evam Streeroga , 5Th floor academic building ITRA Jamnagar Gujarat 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
07889126077 |
| Fax |
|
| Email |
mamtak01797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Hetal Baraiya |
| Designation |
Associate professor |
| Affiliation |
Institue of Teaching and Research in ayurveda,INI, Jamnagar |
| Address |
Department of prasutitranta Evam Streeroga , 5Th floor academic building ITRA Jamnagar Gujarat 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9925954927 |
| Fax |
|
| Email |
hpbaria@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vd Hetal Baraiya |
| Designation |
Associate professor |
| Affiliation |
Institue of Teaching and Research in ayurveda,INI, Jamnagar |
| Address |
Department of prasutitranta Evam Streeroga , 5Th floor academic building ITRA Jamnagar Gujarat 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9925954927 |
| Fax |
|
| Email |
hpbaria@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Institute of Teaching and Research in Ayurveda, Opp.City B division Police station, Gurudwara road, Jamnagar Gujarat |
| 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 Mamta Kumari |
Institute of Teaching and Research in Ayurveda Hospital |
OPD no.5 Prasuti OPD, Institute of Teaching and Research in Ayurveda Hospital, Opposite to B divison police station, Jamnagar 361008 Jamnagar, Gujarat
Jamnagar
GUJARAT |
07889126077
mamtak01797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Institute of Teaching and Reserach in Ayurveda Jamnagar |
Approved |
| Institutional Ethics Committee , Institute of Teaching and Reserach in Ayurveda Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O41||Other disorders of amniotic fluidand membranes. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | L-arginine Sachet | L-arginine sachet 10gm into divided doses with water orally for 15 days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Kushmanda Granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: Bhava Mishra “Bhav Prakash Samhita” by Chowkhamba Sanskrit Series Office, Varanasi, second edition 2002, Shaka Varga page no. 360 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Female |
| Details |
Pregnant women with equals to or more than 24 and equals to or less than 36 weeks Period of Gestation,Singleton pregnancy,Membrane should be intact,Patients with Amniotic fluid index equals to more than 4 or equals to or less than 8, Both primi gravida and multigravida
|
|
| ExclusionCriteria |
| Details |
Multiple pregnancies,Premature rupture of membrane,Pregnant women with HIV, HbsAg, VDRL, HCV positive, known case of Diabetes mellitus or diagnosed with Gestational Diabetes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increment of AFI. |
During the treatment period of 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Maternal weight, Foetal weight
Change in pregnancy associated physiological hindrances such as Daurbalya, Angamarda, Aruchi, Malabaddhata, Udarashoola, Katishoola, Padashoola, Anidra
|
During the treatment period of 15 days and 1 week after completion of treatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Information on
the Trial procedure and Drug: Here in Group A- Kushmanda Granules 5 gm orally twice a day with milk for 15 days. In
Group B- L- arginine sachet 10gm in divided doses orally with water. We
assure that we will prepare formulations as per S.O.P in the pharmacy of
I.T.R.A.
Description of the Process: In present study, participants who will be clinically diagnosed
and confirmed cases of Garbhodaka Kshaya (Oligohydramnios) enlisted in
inclusion criteria will be enrolled. All
patients will be divided into two groups by computer generated randomisation
technique, having minimum of 10 patients in one group. Group A will be given
with Kushmanda Granules 5 gm orally twice a day with milk for 15
days. And Group B will be given with L- arginine sachet 10gm in divided doses orally with
water
Follow-up:
Patients will be advised to visit
the hospital every 5th day during the treatment for
15 days and then
after7 days after treatment as a follow up.
Side Effects: We will follow closely and
keep track of any unwanted effects. We may use some other medicines or stop
the usage of
drug to decrease the symptoms of the side effects.
Results: The efficacy of the therapy
will be assessed on the basis of subjective and objective criteria.
Benefits: Project will help us to resolve the research question. There may not be
any benefit for the society at this stage of the research, but future
generations are likely to be benefited as to find out proper treatment protocol
for the management of Garbhodaka Kshaya (Oligohydramnios). Collected
information from this research project will be kept confidential, all outcomes will be noted in tabular form
and appropriate statistical tests will be applied to compare the effect |