| CTRI Number |
CTRI/2025/02/080395 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A role of saraswat Ghrita and Chaturbhadra Kalpa Basti in the management of delayed milestones in Children |
|
Scientific Title of Study
|
An Open labelled Non Randomised Parallel group clinical controlled trial on Saraswata Ghrita ( oral) and Chaturbhadra Kalpa Basti in the management of Global developmental delay (GDD) in Children |
| 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 Mamta Chandra |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic college and hospital lucknow |
| Address |
P.G. Dept. of Kaumarabhritya OPD NO.1 , State Ayurvedic college and hospital ,lucknow
Lucknow
UTTAR PRADESH
226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7985994287 |
| Fax |
|
| Email |
mamtachandra14794@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi |
| Designation |
Asst. Professor |
| Affiliation |
State Ayurvedic college and hospital lucknow |
| Address |
P.G. Dept. of Kaumarabhritya OPD NO.1 , State Ayurvedic college and hospital ,lucknow
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi |
| Designation |
Asst. Professor |
| Affiliation |
State Ayurvedic college and hospital lucknow |
| Address |
P.G. Dept. of Kaumarabhritya OPD NO.1 , State Ayurvedic college and hospital ,lucknow
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and hospital,Turiyaganj, tulsidas Marg, Lucknow, Uttar Pradesh
Pincode 226003 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic college and hospital lucknow |
| Address |
Tulsidas Marg ,old Haidar, Lucknow 226003 |
| Type of Sponsor |
Government 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 Mamta Chandra |
State Ayurvedic college and hospital Lucknow |
Department of Kaumarabhritya OPD No.1, State Ayurvedic college and hospital Tulsidas Marg, lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
7985994287
mamtachandra14794@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics committee, State Ayurvedic College and hospital lucknow, lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors. Ayurveda Condition: BALA-PAKSHAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saraswata Ghrita , Reference: Bhava Prakash Madhayam khand 24/46,47, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 84 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | Chaturbhadra Kalp Basti | (Procedure Reference: Kashyap Khila asthana 8/23-24, Procedure details: There is use of 4 sneha Basti in beginning , 4 niruha basti in mid, 4 sneha basti
12 day as per schedule )
(1) Medicine Name: Saraswata Ghrita , Madhu tailik , Reference: Bhava prakash madhayam khand 24/46 , sushrut chikitsa 38/100-101, Route: Rectal, Dosage Form: Ghrita, Dose: 100(ml), Frequency: od, Duration: 12 Days |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Child between age Group of 1-5 yr of either sex are diagnosed GDD
2 .Child / parents willing to participate in the Trial.
3. Children with developmentaldisabilities of both physical and mental ( delayed
milestone)
4. Unable to stand , walk, speech, sitting as per age.
5. Child with altered IQ as per age.
6. Child with altered social & behaviour as per age |
|
| ExclusionCriteria |
| Details |
1.Child of age less then 1 year. and more then 5 years.
2.Child with sever infection, systemic illness like TB. Gastrointestinal disease
3.Child with genetic disorder like down syndrome or any congenital anomalies
4.Child suffering from any muscular dystrophy (DMD)
5.Child having abnormal CT/MRI brain finding with abnormal EEG finding
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in quality of life in children .
2. Improvement in speech/language/Communication/sociability/sensory/cognitive awareness , locomotary disability. |
After 84th day of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To Check the efficacy of Saraswata ghrita in the case of GDD.
•To evaluate the role of Chaturbhadra kalp basti in GDD. |
1st,36th,72th,84th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="0"
Months="2"
Days="24" |
|
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
|
Global Developmental delay ( GDD ) is one of the most steadily rising complex neuromuscular developmental disorder in past few decades, but there is no certain treatment available in any modalities. Ayurveda is the ray of hope for such kind of clinical conditions.Therefore, I select this trial. Clinical trial will be done on two group A and B . In group A Saraswata ghrita using route of administration as Paan (Oral route) for 84 day’s without any gap and In Group B Chaturbhadra Kalp Basti (Per rectal route) ,12 day schedule ( 4 sneha vasti in beginning, 4 niruh vasti in mid, 4 sneha vasti in last ). Minimum 30 GDD diagnosed children, aged 1 to 5 years clinically studies of treatment modules. Each segment of treatment module will be for 84 day’s. After, each treatment there is a gap of 24 days in group B, Total duration of trial is 84 days. A follow up will be done after 30 days of complete clinical trial. |