| CTRI Number |
CTRI/2025/09/094226 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF KUSHMAND AVLEHA IN CHILDHOOD KARSHYA |
|
Scientific Title of Study
|
To Evaluate The Effect Of Kushmand Avleha in Childhood Karshya |
| 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 Keerti Verma |
| Designation |
Head of Department |
| Affiliation |
Rishikul Campus,hARIDWAR |
| Address |
Department of Kaumarbhritya,OPD No.10,Rishikul Campus,
Devpura,Haridwar,Uttrakhand,India,249401,India,
Department of Kaumarbhritya,Sushruta Bhawan,Floor no.1,Rishikul Campus,Haridwar,Uttrakhand,249401,India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9997777833 |
| Fax |
|
| Email |
keerti.vrm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keerti Verma |
| Designation |
Head of Department |
| Affiliation |
Rishikul Campus,hARIDWAR |
| Address |
Department of Kaumarbhritya,OPD No.10,Rishikul Campus,
Devpura,Haridwar,Uttrakhand,249401,India,
Department of Kaumarbhritya,Sushruta Bhawan,Floor No.1,Rishikul Campus,
Devpura,Haridwar,Uttrakhand,249401,India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9997777833 |
| Fax |
|
| Email |
keerti.vrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keerti Verma |
| Designation |
Head of Department |
| Affiliation |
Rishikul Campus,hARIDWAR |
| Address |
Department of Kaumarbhritya,OPD No.10,Rishikul Campus,
Devpura,Haridwar,Uttrakhand,249401,India,
Department of Kaumarbhritya,Sushruta Bhawan,Floor No.1,Rishikul Campus,
Devpura,Haridwar,Uttrakhand,249401,India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9997777833 |
| Fax |
|
| Email |
keerti.vrm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus Ayurved University, Haridwar,Uttrakhand,India,249401 |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Ayurved University |
| Address |
Department of Kuamarbhritya,OPD No.10,Rishikul Campus,Haridwar,Uttrakhand,249401,India, |
| 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 Priyanka Mehra |
Rishikul Ayurveda Campus |
Department of Kaumarbhritya,OPD No.10,Rishikul Campus,Devpura, Haridwar,UTTARAKHAND,India,249401
Hardwar
UTTARANCHAL |
9536701242
mehrapriyanka8888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA), (2) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA), (3) ICD-10 Condition:E43||Unspecified severe protein-caloriemalnutrition. Ayurveda Condition: KARSY, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KUSHMAND AVLEHA, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.The children between the age group of 1-5 years irrespective of their gender, caste, religion and socio-economic condition.
2.Children diagnosed as the case of Karshya presenting symptoms.
3.Children fulfilling the diagnostic criteria of IAP for Malnutrition of Grade I and Grade II.
|
|
| ExclusionCriteria |
| Details |
Patient below the age group 1 year & above 5 years.
2.According to IAP classification more than 80% (normal) & less than 61% (Nutritional grade III & IV) are excluded.
3.Patients with oedema.
4.Patient associated with known cases of systemic infections and other disorders like tuberculosis, HIV, congenital & hereditary problems, neurological & endocrine disorders, Liver disorders, anatomical defects, cerebral palsy,nephrotic syndrome, malabsorption syndrome, malignancies, Lactose intolerance, etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Kushmand Avleha in Childhood Karshya.
Subjectively all signs and symptoms are given with mild and moderate grading of IAP depinding upon severity of malnutrition.
|
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Kushmand Avleha in Childhood Karshya.
Subjectively all signs & symptoms are given with grading depending upon their severity |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Thesis, Research article
- For how long will this data be available start date provided 15-10-2026 and end date provided 15-10-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Malnutrition is the the cellular imbalance between the
supply of nutrients and energy and the body’s demand for them to ensure growth, maintenance, and specific functions. Karshya is mentioned as Apatarpanajanya vyadhis in Ayurveda. According to Acharya
Charaka over lean (Karshya)
persons are described under eight despicable persons (Ashtau-ninditiya) along with over
obese (Medasvi) person. According
to Acharya Sushruta, lean and
fattiness of body depends upon Rasa-dhatu. In
the Ayurveda literature alpa-bhojanata, asamyaka-bhojnata result
in Kuposhana and its progressive
manifestations cause diseases such as Karshya,
Phakka Roga, Parigarbhika and Balashosha which are known as Kuposhanajanyavyadhi in children. The drug for this trial is Kushmand Avleha and the study aims to evaluate the effect of Kushmand Avleha in mild and moderate cases of Karshya. Duration of treatment is of 90 days in total on daily basis of follow up. Patients will be registered from OPD and IPD of PG Department of Kaumarbhritya, Rishikul Campus, Haridwar, Uttarakhand Ayurved University, Dehradun, Uttarakhand.
|