| CTRI Number |
CTRI/2024/05/067947 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To rule out the ability of Samvardhan Leha and Yoga Basti on Cerebral Palsy |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Samvardhan Leha and Yoga Basti on Cerebral Palsy 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 |
Prof Rakesh Sharma |
| Designation |
Prof and Head, Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College PaprolaTeh Baijnath Distt Kangra HP |
| Address |
Room No.217,Anatomy Block Rajiv Gandhi Govt.Post Graduate Ayurvedic College and Hospital, Paprola,Distt. Kangra, Himachal Pradesh 176115
Pandol Road, Teh-Baijnath, Distt.-kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rakesh Sharma |
| Designation |
Prof and Head, Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College PaprolaTeh Baijnath Distt Kangra HP |
| Address |
Room No.217,Anatomy Block Rajiv Gandhi Govt.Post Graduate Ayurvedic College and Hospital, Paprola,Distt. Kangra, Himachal Pradesh 176115
Pandol Road, Teh-Baijnath, Distt.-kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani |
| Designation |
MD Scholar |
| Affiliation |
RGGPG Ayurvedic College PaprolaTeh Baijnath Distt Kangra HP |
| Address |
Rajiv Gandhi Govt.Post Graduate Ayurvedic College and Hospital, Paprola,Distt.Kangra Himachal Pradesh,176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219533006 |
| Fax |
|
| Email |
drshivani411@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, Distt.Kangra,HP,India 176115
Herbal Garden and Herbarium, Research Institute in ISM, Jogindernagar, Distt.Mandi HP,INDIA,175015 |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra,H.P.176115 |
| 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 |
| Prof DrRakeshSharma |
RGGPG Ayurvedic College,Paprola |
Room no.217, RGGPGAyu.College, Paprola,Teh.Baijnath,Distt.Kangra, H.P.,176115, Kangra,Himachal Pradesh
Kangra
HIMACHAL PRADESH |
9418105049
hodkbpaprola8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental disorders. Ayurveda Condition: VATAPRAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Samvardhan Leha, Reference: Kashyap samhita Sutra Sthan Lehan adhyaya P No.8, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Lukewarm milk), Additional Information: - | | 2 | Intervention Arm | Procedure | - | yoga-bastiH, योग-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Sidhi sthan 1/47-48, Procedure details: (Procedure Reference: Charak Sidhi sthan 1/47-48 , Procedure details: Procedure Reference: Charak Sidhi sthan 1/47-48 Procedure details: (Procedure Reference: Charak Sidhi 1/47-48, Procedure details: Route-Anal Route. Dose-Anuvasana Basti with ksheer Bala taila-30-160ml according to age pf patient,Niruha Basti(Madhutailila Basti)-90-480ml according to age of patient. Duration-8 days))
|
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient between 2 to16 years of age.
2. Children with developmental disability both either physical or mental, in mild to
moderate degree as compared to other normal children. |
|
| ExclusionCriteria |
| Details |
1. Patient below 2 years of age and above 16 years.
2. Patient of cerebral palsy with congenital heart disorder, a severe concurrent illness
and other diseases like Juvenile Diabetes, Renal impairment etc. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of Objective and Subjective criteria |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Control of cerebral palsy patients |
45 days |
|
|
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 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="0"
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
|
I would like to publish my research trial after completion as soon as possible. A total 20 subjects will be studied in two groups. 10 Patients will be managed with Udvartana, Shashtishali pinda sweda, Yoga Basti and 10 Patients will be managed with Udvartana, Shashtishali pinda sweda and Samvardhan Leha. The outcome will be analysed based on subjective and objective parameters with appropriate statistical tools. |