| CTRI Number |
CTRI/2024/06/069171 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two Ayurvedic Avaleha formulations,Kushmanda Kalyanaka and Ashwagandhadi Lehya in the patients of Karshya (Underweight) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Assess The Efficacy Of Kushmanda Kalyanaka In 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 Anagha Gulhane |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College, Vidhyagiri, Moodabidire, D.K
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9049895870 |
| Fax |
|
| Email |
agulhane21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Pai |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College, Vidhyagiri, Moodabidire, D.K
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8921385332 |
| Fax |
|
| Email |
drsurpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surekha Pai |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College, Vidhyagiri, Moodabidire, D.K
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8921385332 |
| Fax |
|
| Email |
drsurpai@gmail.com |
|
|
Source of Monetary or Material Support
|
| All Ayurvedic Textbooks.
Modern Textbooks.
Disease Related Articles.
Previous Works Done. |
|
|
Primary Sponsor
|
| Name |
Dr Anagha Gulhane |
| Address |
Alvas Ayurveda Medical College, Vidhyagiri, Moodabidire, D.K |
| Type of Sponsor |
Other [Self] |
|
|
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 Anagha Gulhane |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodabidire, D.K. |
PG Department of Kayachikitsa Alvas Ayurveda Medical College, Vidhyagiri, Moodabidire, D.K
Dakshina Kannada
KARNATAKA |
9049895870
agulhane21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College, Vidyagiri, Moodabidire, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushamanda Kalyanaka Avalehya, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandhadi Lehya, Reference: Sahasrayoga, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients between the age group of 16 to 60 years.
2) Patient having at least one of the Nidana mentioned in Ayurvedic literature for Karshya will be included.
3) Patient willing to sign Written Consent Form. |
|
| ExclusionCriteria |
| Details |
1) Patients with Karshyatha due to Tuberculosis, Malignancies and metabolic disorders.
2) Patients with any other systemic disorders which will interfere the study will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient will be checked for following symptoms:
1) Prominent Vascular Network
2) Intolerence to Physical work
3) Intolerence to Hunger and Thrist
4) Prominent Joints And Bones |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The below Criteria will be Checked on 0Th day, 46th Day and 61st Day.
1) Weight
2) BMI
3) Circumference of Neck , Mid arm, Abdomen.
4)Waist-Hip Ratio |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/06/2024 |
| 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="1"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized, single blind, parallel group, actively controlled clinical study with comparative standard drug - Ashwagandhadi Lehya and interventional drug - Kushmanda Kalyanaka Avaleha with the dosage12 gms (Total: 24gms per day) empty stomach before to the meals as BID. This study is conducting on patients of Karshya belongs to age of 16yrs to 60yrs who gives written and verbal consent for undergoing clinical study. Study will be conducting in Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri. Interventional period of this study is 60 days. Assessment will be done on 0th Day, 46th Day, 61st Day. |