CTRI Number |
CTRI/2023/06/053628 [Registered on: 07/06/2023] Trial Registered Prospectively |
Last Modified On: |
05/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Ayurveda Management Of Global Developmental Delay |
Scientific Title of Study
|
Clinical Study To Evaluate The Combined Effect Of Panchagavya Ghrita And Selected Ayurveda Treatment Modality As An Early Intervention In The Management Of Global Developmental Delay. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR ANJITH C BABU |
Designation |
PG Scholar |
Affiliation |
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan |
Address |
Department Of Kaumara Bhritya Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan 573201 Thanniruhalla Hassan, 573201 Hassan KARNATAKA 573201 India |
Phone |
7996602710 |
Fax |
|
Email |
anjith.babu2@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR VIJAYALAXMI MALLANNAVAR |
Designation |
HOD, Associate professor |
Affiliation |
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan |
Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan Thanniruhalla, Hassan Hassan KARNATAKA 573201 India |
Phone |
9480624829 |
Fax |
|
Email |
drvijayalaxmim@sdmcahhassan.org |
|
Details of Contact Person Public Query
|
Name |
DR VIJAYALAXMI MALLANNAVAR |
Designation |
HOD, Associate professor |
Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan |
Address |
Department Of Kaumarabhritya
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan Thanniruhallla, Hassan,573201 Hassan KARNATAKA 573201 India |
Phone |
9480624829 |
Fax |
|
Email |
drvijayalaxmim@sdmcahhassan.org |
|
Source of Monetary or Material Support
|
sri dharmasthala manjunatheswara college of ayurveda and hospital |
|
Primary Sponsor
|
Name |
DR ANJITH C BABU |
Address |
Department Of Kaumarabhritya Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan |
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 ANJITH C BABU |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan Hassan KARNATAKA |
7996602710
anjith.babu2@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: VATAVYADHIH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Ashtanga Hrudayam , Procedure details: Matra basti with Panchagavya Ghrita 10 Ml once a day immediately after food ) (1) Medicine Name: Panchagavya Ghrita , Reference: Bhaishajya Ratnavali , Route: Rectal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 20 Days | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchagavya Ghrita, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 68 Days, anupAna/sahapAna: Yes(details: Honey ), Additional Information: - | 3 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Ashtanga Hrudayam , Procedure details: Prathimarsha Nasya with Panchagavya Ghrita 2 drops twice a day ) (1) Medicine Name: Panachagavya Ghrita, Reference: Bhaishajya Ratnavali , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 68 Days |
|
|
Inclusion Criteria
|
Age From |
6.00 Month(s) |
Age To |
2.00 Year(s) |
Gender |
Both |
Details |
1.Children between the age group of 6 months to 24 months irrespective gender fulfilling the
diagnostic criteria(DEVELOPMENTAL ASSESSMENT SCALE FOR INDIAN INFANTS DASII)
2.The children whose parents are willing to participate their child in the study and ready to
sign the consent form |
|
ExclusionCriteria |
Details |
1. Children K/C/O Genetic & Chromosomal Abnormalities
2. Inborn Errors of Metabolism
3. All Diagnosed cases of congenital anomalies, protein energy malnutrition, rickets, |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Improvements in attainment of age-appropriate developmental milestones after intervention which were delayed during the initial assessment will be re- assessed using DASII ( Developmental Assessment Scale For Indian Infants) |
0/90 DAY |
|
Secondary Outcome
|
Outcome |
TimePoints |
General improvement in the quality of children with developmental delays is assessed during the course of intervention between & after the completion of the intervention using CDC Grading. |
1/10/45/56/90 day |
|
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 2/ Phase 3 |
Date of First Enrollment (India)
|
18/06/2023 |
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 Yet Recruiting |
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
|
Global developmental delay is one of the major issues of concern during the early childhood which is unnoticed due to lack of early screening. The prevalence of Global developmental delay in children under 2 years of age in India is 1.5 to 2.5 % among the live births1.Growth and development occurs simultaneously as a continuous process. Growth denotes the quantitative increase in the cell mass whereas Development is the gradual and systematic maturation of the nervous system. Maturity of the central nervous system, which is very much essential for a child to learn particular skill or to achieve a milestone. Growth being a quantitative parameter, growth retardations are identified at the earliest. Whereas normal developmental pattern is assessed using different developmental milestones, which are unnoticed due to lack of awareness and tendency to pretend it as normal even if there is lag or delay. Global developmental delay can be defined as the failure to attain the age-appropriate developmental milestones in 2 or more domains of development. Development depends on the functional maturation of the nervous system. As the brain matures, certain primitive reflexes are lost and specific milestones are achieved. If the primitive reflexes are persisting beyond the expected age of regression, it is an early indicator for developmental delay. Previous studies suggest that early screening, identification and early intervention has shown considerable improvement in the condition2. Stimulation through Ayurveda procedures as an early intervention is a new ray of hope for a healthy future among the kids with developmental delay. Masthishka abhighata can be considered as one among the cause for developmental delay. In Bhaishajyaratnavali in the context of Mastishkachayaapachaya, Panchagavya ghrita is mentioned as Rasayana3. Hence the present study is planned to evaluate the effect of administration of Panchagavya ghrita in various forms (Basthi, Pratimarsha nasya & oral intake) as an early intervention along with external stimulation procedures like Sarvanga abhyanga and Parisheka. |