| CTRI Number |
CTRI/2025/06/089102 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Effect of two Ayurvedic formulation in karshya |
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Scientific Title of Study
|
TO EVALUATE THE EFFICACY OF ASHWAGANDHA AND VIDARIKANDADI GRANULES IN CHILDHOOD KARSHYA W.S.R TO UNDERNUTRTION IN CHILDREN.
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi jishtu |
| Designation |
PG scholar |
| Affiliation |
Abhilashi Ayurvedic college and Research Institute |
| Address |
Department of Kaumarbhritya
Room no-306 3rd floor
Abhilashi Ayurvedic College and Research Institute Chail Chowk Tehsil Chachyot Distt
Mandi Himachal Pradesh
Abhilashi Ayurvedic College and Research Institute Chail Chowk Tehsil Chachyot Distt Mandi Himachal Pradesh
Mandi
HIMACHAL PRADESH
175028
India |
| Phone |
8544741294 |
| Fax |
|
| Email |
nidhimedico245@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Sharma |
| Designation |
Professor |
| Affiliation |
Abhilashi Ayurvedic college and Research Institute |
| Address |
Department of Kaumarbhritya
Room No-306,3rd floor
Abhilashi Ayurvedic College and Research Institute Chail chowk Tehsil Chachyot Distt Mandi
Department of Kaumarbhritya
Room No-306,3rd floor
Abhilashi Ayurvedic College and Research Institute Chail chowk Tehsil Chachyot Distt Mandi
Mandi
HIMACHAL PRADESH
175028
India |
| Phone |
7018720016 |
| Fax |
|
| Email |
monikasharmaau89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr monika Sharma |
| Designation |
Professor |
| Affiliation |
Abhilashi Ayurvedic college and Research Institute |
| Address |
Department of Kaumarbhritya
Room No-306,3rd floor
Abhilashi Ayurvedic College and Research Institute Chail chowk Tehsil Chachyot Distt Mandi
Department of Kaumarbhritya
Room No-306,3rd floor
Abhilashi Ayurvedic College and Research Institute Chail chowk Tehsil Chachyot Distt Mandi
Mandi
HIMACHAL PRADESH
175028
India |
| Phone |
7018720016 |
| Fax |
|
| Email |
monikasharmaau89@gmail.com |
|
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Source of Monetary or Material Support
|
| Abhilashi Ayurvedic college and Research Institute Chail Chowk Tehsil Chachyot Dist.Mandi Himachal Pradesh 175045 India. |
|
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Primary Sponsor
|
| Name |
Abhilashi Ayurvedic College |
| Address |
Abhilashi Ayurvedic College Chail chowk Dist.Mandi Himachal Pradesh |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi |
Abhilashi Hospital |
Department of Kaumarbhritya
Room No-306,3rd floor
Abhilashi Ayurvedic College and Research Institute Chail chowk Tehsil Chachyot Distt Mandi
Mandi
HIMACHAL PRADESH |
08544741294
nidhimedico245@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Abhilashi Ayurvedic College and Research Institute Chail chowk |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E42||Marasmic kwashiorkor. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha , Reference: Bhaisajya Ratnavali Balrog chikitsa chapter no -71/132, Route: Oral, Dosage Form: Khanda /Granules, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidarikand, Reference: yogratnaker page no 844, shloka 78, Route: Oral, Dosage Form: Khanda /Granules, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: - |
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patient having clinical sign and symptoms of Karshya as per clinical Ayurveda literature. |
|
| ExclusionCriteria |
| Details |
1) Patient suffering from malnutrition grade 3 and 4
2)Patient with congenital anomaly and physical disability
3) Patient associated with known case of systemic infection and other disorder like TB, HIV, hereditary problems, neurological, endocrine, liver disorders, anatomical defect, cerebral palsy, nephrotic syndrome, malabsorption syndrome, malignancies and lactose intolerance. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Effect of two therapies on body weight and classical symptoms of Karshya. |
6 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of two drug therapies on body weight and classical symptoms of Karshya. |
43 days |
|
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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" |
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Phase of Trial
|
Phase 2 |
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Date of First Enrollment (India)
|
03/07/2025 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The Research aim to evaluate the efficacy of Ashwagandha granules and Vidarikandadi granules in treating childhood karshya [undernutrition] .the study involves a clinical trial with 40 children aged 3 -16 ,Divided into two groups: one receiving Ashwagandha granules and Vidarikandadi granules in treating childhood karshya [undernutrition].The study involves a clinical trial with 40 children aged 3-16, divided into 2 groups : one receiving ashwagandha granules and other Vidarikandadi granules, both administered orally for 43 days the trial includes assessment based on subjective and objective health parameters, with follow up conducted at specified intervals. |