| CTRI Number |
CTRI/2025/05/087373 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Assess the Ability of Vidarikandadi Yoga and Ksheerbala Taila Matra Basti in Karshya w.s.r. toUndernutrition in childern |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Vidarikandadi Yoga and Ksheerbala Taila Matra Basti in Karsha w.s.r. to Undernutrition in childern. |
| 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 and Hospital, Paprola, Kangra, H.P. |
| Address |
Room no 217, Anatomy block, RGGPG Ayurvedic college and Hospital, Paprola, Baijnath, 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 and Hospital, Paprola, Kangra, H.P. |
| Address |
Room no 217, Anatomy block, RGGPG Ayurvedic college and Hospital, Paprola, Baijnath, Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kulbhushan Chauhan |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic college and Hospital, Paprola, Baijnath, Kangra, H.P. |
| Address |
Room No. 217, Department of Kaumarbhritya, RGGPG Ayurvedic college and Hospital, Paprola, Baijnath, Kangra, H.P.
Room No. 217, Department of Kaumarbhritya, RGGPG Ayurvedic college and Hospital, Paprola, Baijnath, Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805860013 |
| Fax |
|
| Email |
kchauhan27185@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charaka Govt. Ayurvedic Pharmacy, Paprola, Distt. Kangra Pin code 176115
Herbal Garden and Herbarium, Research Institute in ISM, Jogindernagar, Distt. Mandi Pin code 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 |
| Dr Rakesh Sharma |
RGGPG Ayurvedic College and Hospital, Paprola |
Room No. 217, Department of Kaumarbhritya, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, H.P.
176115
Kangra
HIMACHAL PRADESH |
9418105049
hodkbpaprola8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE (HUMAN) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K909||Intestinal malabsorption, unspecified. Ayurveda Condition: ATIKARSYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charaka Siddhi Sthana 4/54, Procedure details: 20 patients will be managed with Ksheerbala taila Matrabasti, Dose will be decided according to Acharya Kashyapa Khila Sthana 8/104-109.
Administration schedule will be of 21 days (3 sittings of 7 days with 3 days interval))
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidarikandadi Yoga, Reference: Bhavprakash Madhyama Khand 71/170, Route: Oral, Dosage Form: Churna/ Powder, Dose: 15(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Lukewarm milk), Additional Information: 20 patients will be managed with Vidarikandadi Yoga |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient between 2-12 years of age.
2. Moderate patients of undernutrition ( as per WHO classification of PEM)
3. Parents / Guardians of the children willing to participate in the research trial. |
|
| ExclusionCriteria |
| Details |
1. Patients below 2 years of age and above 12 years.
2. Patients suffering from severe malnutrition.
3. Patients suffering from chronic illness like malignancy, pneumonitis, pleural effusion, pulmonary TB and juvenile Diabetes mellitus.
4. Patient with physical disability and congenital anomalies.
5. Parents / Guardians of the children not willing to participate in the research trial.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fulfilment of Subjective and Objective criteria
Assessing the efficacy of Vidarikandadi Yoga and Ksheerbala tail Matra basti on Karshya in children
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevention of undernutrition in children
Evaluation of clinical safety of Vidarikandadi Yoga on Karshya in children
Evaluation of clinical safety of Ksheerbala Taila Matra basti on Karshya in children |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2025 |
| 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="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
|
20 patients will be treated with Vidarikandadi yoga and 20 patients will be managed with Ksheerbala Taila Matra basti to compare the efficacy in Karshya w.s.r. to Undernutrition in children. Assesment and evaluation of Vidarikandadi Yoga and Ksheerbala Taila Matra basti and comparing their clinical safety. |