| CTRI Number |
CTRI/2024/05/067467 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| 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
|
The effect of Guduchi drops in Neonatal Jaundice |
|
Scientific Title of Study
|
A Randomized Controlled Clinical study to Evaluate the Efficacy of Guduchi (Tinospora Cordifolia) Drop in Physiological Neonatal Jaundice. |
| 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 Sachin Rameshwar Bhagwat |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y.Patil College of Ayurved and Research Centre , Pimpri, Pune |
| Address |
OPD NO.1,Department of Kaumarbhritya, Dr.D.Y.Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9511223623 |
| Fax |
|
| Email |
sbhagwat777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Khawale |
| Designation |
Professor and HOD |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| Address |
OPD NO.1,Department of Kaumarbhritya, Dr.D.Y.Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9923220055 |
| Fax |
|
| Email |
drdeepak77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Khawale |
| Designation |
Professor and HOD |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| Address |
OPD NO.1,Department of Kaumarbhritya, Dr.D.Y.Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9923220055 |
| Fax |
|
| Email |
drdeepak77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO.1, Dr. D.Y.PATIL college of Ayurved and research Centre, Pimpri, Pune-411018 |
|
|
Primary Sponsor
|
| Name |
Dr. Sachin Rameshwar Bhagwat |
| Address |
OPD NO.1, Dr. D.Y.PATIL college of Ayurved and research Centre, Pimpri, Pune-411018 |
| 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 Sachin Bhagwat |
Dr.D.Y.Patil College of Ayurved and Research Centre,Pune |
OPD NO.1,Department of Kaumarbhritya, Dr.D.Y.Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA |
9511223623
sbhagwat777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:P599||Neonatal jaundice, unspecified. Ayurveda Condition: KAMALA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Phototherapy | Phototherapy will be given in controlled group. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GUDUCHI DROP, Reference: CHARAK SAMHITA, Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 7(drops), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Day(s) |
| Age To |
15.00 Day(s) |
| Gender |
Both |
| Details |
1.Neonate with Total bilirubin 11mg/dl to 15 mg/dl.
2. Patients with Physiological Neonatal Jaundice.
3. Age- 3rd to 15th day of life.
4. Weight – 2.5 to 4 kg
|
|
| ExclusionCriteria |
| Details |
Bilirubin level more than 15mg /dl
Patients with Pathological Neonatal Jaundice.
Newborn with Rh Incompatibility and ABO Incompatibility.
Newborn with history of Birth Asphyxia.
Neonatal Septicemia.
Neonates should be free from Medical emergencies and Surgical interventions.
Low Birth weight and Preterm Neonates.
Newborn with any other Systemic disease along with Neonatal Jaundice.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO decrease level of serum Bilirubin |
0,3,5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To avoid need of Phototherapy and its complications |
0,3,5 days |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
01/06/2024 |
| 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="8"
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
|
The present Randomised controlled study in Neonatal Jaundice will be carried out with interventional drug as Guduchi Drop and Controlled treatment as Phototherapy. |