| CTRI Number |
CTRI/2019/07/020324 [Registered on: 23/07/2019] Trial Registered Prospectively |
| Last Modified On: |
18/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of AYUSHMANAS a coded drug in Cognitive deficit |
|
Scientific Title of Study
|
Randomised placebo controlled double blind clinical trial on the efficacy of AYUSHMANAS in the management of Smriti dourbalya (Cognitive deficit)†|
| Trial Acronym |
AYUSHMANAS in CD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G V RAMANA |
| Designation |
R O (Ay) Scientist 3 |
| Affiliation |
CCRAS MINISTRY OF AYUSH |
| Address |
Research officer (AY) Scientist 3
Room no- 4, Advanced centre for Ayurveda in Mental health and Neurosciences
NIMHANS campus Hosur road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9448346641 |
| Fax |
08026567546 |
| Email |
gvr1528@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G V RAMANA |
| Designation |
R O (Ay) Scientist 3 |
| Affiliation |
CCRAS MINISTRY OF AYUSH |
| Address |
Research officer (AY) Scientist 3
Room no- 4,
Advanced centre for Ayurveda in Mental health and Neurosciences
NIMHANS campus Hosur road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9448346641 |
| Fax |
08026567546 |
| Email |
gvr1528@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G V RAMANA |
| Designation |
R O (Ay) Scientist 3 |
| Affiliation |
CCRAS MINISTRY OF AYUSH |
| Address |
Research officer (AY) Scientist 3
Room no- 4,
Advanced centre for Ayurveda in Mental health and Neurosciences
NIMHANS campus Hosur road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9448346641 |
| Fax |
08026567546 |
| Email |
gvr1528@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES MINISTRY OF AYUSH GOVT OF INDIA |
|
|
Primary Sponsor
|
| Name |
CCRAS MINISTRY OF AYUSH |
| Address |
NO 61-65, opp. D Block
Janakpuri,
New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 G V Ramana |
Advanced centre for Ayurveda in Mental Health and Neurosciences |
NIMHANS CAMPUS
HOSUR ROAD
BENGALURU
Bangalore
KARNATAKA |
9448346641
08026567546
gvr1528@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70||Mild intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
Group I:
1. AYUSHMANAS(Coded drug)
Dose : 250mg x 2 tab b i d
Form of Administration : Tablet
Route of Administration : Oral
Time of Administration : Twice a dayafter food.
Packing form : 120tab / Pet jar
Anupana : Water
Duration of therapy : 6 months (120 days)
|
| Comparator Agent |
Group 2 |
Group II:
Placebo tablet:
Dose : 250mg x 2tab b i d
Form of Administration : Tablet
Route of Administration : Oral
Time of Administration : Twice a dayafter food.
Packing form : 120tab / Pet jar
Anupana : Water
Duration of therapy : 6 months (120 days)
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of either sex aged in between 8 to 13 years.
2. Children with Intelligence Quotient 63 – 80 as per BKT
3. Willing and able to participate for 6 months
(Consent to be obtained from Parent(s) / Guardian(s)/ Assent from children wherever possible).
|
|
| ExclusionCriteria |
| Details |
1. Children with a history of peptic ulcer disease, any gastric or duodenal surgery, gastrointestinal (GI) bleeding or other GI disorders.
2. Children with severe infection and/or clinically significant hepatic, respiratory, renal, cardiac or hematological disorders.
3. Children with abnormal laboratory values at admission in to the study: serum creatinine 1.2 > mg/dl, SGOT, SGPT >3times upper limit of normal; serum Bilirubin or Alkaline phosphatase >1.5 times upper limit of normal
4. Patient’s guardian who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
5. The Children had any intramuscular, intra-articular or intravenous carticosteroids within 4 weeks prior to study entry.
6. The Children with a history of recent and clinically significant drug abuse.
7. The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia, thrombocytopenia etc.
8. The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to return for follow-up visits, and unlikelihood of complete study.
9. Children in whom another investigational drug was used with in 3 months prior to entry in this study.
10. Children with poorly controlled epilepsy
(H/o attack in last 3 months).
11. Children to whom BKT can’t be administered for any reason
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical efficacy of AYUSHMANAS in the Management of Smriti Daurbalya. |
The outcome shall be assessed periodically every 30 days once till the completion of 6 months intervention period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety of AYUSHMANAS in the children suffering from Smriti Daurbalya. |
duration of study 3 years
intervention period 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2019 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The current research study is aimed to assess the efficacy and safety of a coded Ayurvedic drug AYUSHMANAS. The ingredients of the trial drug have been proven to be safe in toxicity studies conducted in India and abroad. Need and significance of the study: As there is no effective therapy in conventional system many patients seek alternative methods of treatment for Smritidourbalya. Thus there is a definite need to scientifically assess some of alternative treatment modalities. In light of above, the present study has been proposed to evaluate the role of AYUSHMANAS in SmritiDaurbalya (Cognitive deficit).
Objectives: PrimaryObjectives: To assess the clinical efficacy of AYUSHMANAS in the Management of SmritiDaurbalya (CD). SecondaryObjectives: To assess the clinical safety of AYUSHMANAS in the children suffering from SmritiDaurbalya (CD). Brief research plan: The clinical study will be conducted in two groups. The cases will be assigned randomly in to two groups. The intervention will be as follows. Group I: 1. AYUSHMANAS(Coded drug) Dose : 250mg x 2 tab b i d Form of Administration : Tablet Route of Administration : Oral Time of Administration : Twice a day after food. Packing form : 120 tab / Pet jar Anupana : Water Duration of therapy : 6 months (180 days) Group II: Placebo tablet: Dose : 250mg x 2 tab b i d Form of Administration : Tablet Route of Administration : Oral Time of Administration : Twice a day after food. Packing form : 120 tab / Pet jar Anupana : Water Duration of therapy : 6 months (150 days) Sample size: Total 150.
|