| CTRI Number |
CTRI/2020/10/028385 [Registered on: 13/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study Of Bruhad Dadimashtaka Churna With Hingwashtaka Churna In The Management Of Loss of Appetite. |
|
Scientific Title of Study
|
A Comparative Study Of Bruhad Dadimashtaka Churna With Hingwashtaka Churna In The Management Of Agnimandya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Nikhil Kailas Dhakare |
| Designation |
PG Scholar |
| Affiliation |
BSDTS Ayurved Mahavidyalaya, Wagholi, Pune-412207 |
| Address |
OPD NO.1,Department of Kayachikitsa
BSDTS Ayurved Mahavidyalaya,
Vishwashanti Dham, Kesnand road, Wagholi, Pune-412207, Maharashtra.
Pune
MAHARASHTRA
412207
India |
| Phone |
8788403755 |
| Fax |
|
| Email |
nikhildhakare0167@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Anjali A Deshpande |
| Designation |
Professor and HOD of Department of Kayachikitsa |
| Affiliation |
BSDTS Ayurved Mahavidyalaya |
| Address |
OPD No. 1,Department of Kayachikitsa
BSDTS Ayurved Mahavidyalaya,
Vishwashanti Dham, Kesnand road, Wagholi, Pune-412207, Maharashtra.
Pune
MAHARASHTRA
412207
India |
| Phone |
9730069747 |
| Fax |
|
| Email |
anjalidesh1610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Anjali A Deshpande |
| Designation |
Professor and HOD of Department of Kayachikitsa |
| Affiliation |
BSDTS Ayurved Mahavidyalaya |
| Address |
OPD No. 1,Department of Kayachikitsa
BSDTS Ayurved Mahavidyalaya,
Vishwashanti Dham, Kesnand road, Wagholi, Pune-412207, Maharashtra.
Pune
MAHARASHTRA
412207
India |
| Phone |
9730069747 |
| Fax |
|
| Email |
anjalidesh1610@gmail.com |
|
|
Source of Monetary or Material Support
|
| BSDTs Ayurved Hospital and Research Center, Vishwashanti Dham, Kesnand road, Wagholi, Pune-412207 |
|
|
Primary Sponsor
|
| Name |
BSDTs Ayurved Hospital and Research Center Wagholi Pune |
| Address |
BSDTs Ayurved Hospital and Research Center, Vishwashanti Dham, Kesnand road, Wagholi, Pune-412207 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vd Nikhil Kailas Dhakare |
BSDTs Ayurved Hospital & Research center |
OPD No 1, Department of Kayachikitsa, BSDTs Ayurved Hospital and research center, Vishwashanti Dham, Kesnand road, Wagholi, Pune-412207
Pune
MAHARASHTRA |
8788403755
nikhildhakare0167@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group B- Hingwashtaka Churna |
Group-B comprising of 32 patients diagnosed as agnimandya will be given Hingwashtaka churna; dosage-2gm; kaal-Pratham kavala for 14 days. Follow-up with assessment on 0th , 8th, 15th & 21st day (Observational follow-up for 7 days after treatment 14 dyas.) |
| Intervention |
Group-A-Bruhad Dadimashtaka churna |
Group-A comprising patients diagnosed as agnimandya will be given Bruhad Dadimashtaka churna; dosage-2gm; kaal-samaan kala for 14 days. Follow-up with assessment on 0th , 8th, 15th & 21st day (Observational follow-up for 7 days after treatment of 14 days.) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients having the following symptoms of Agnimandya:Kshudhamandya (Abhyavaharan shakti, Jaran shakti), Avipak, Prasek, Shirogauav, Udar gaurav, Antrakujan, Pravahan, Gatrasadan, Chhardi. |
|
| ExclusionCriteria |
| Details |
(1) known case of chronic disease like gastric ulcer, duodenal ulcer, cancer, HIV infection & tuberculosis
(2) known case of Diabetes Mellitus
(3) Any reported morbid conditions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bruhad Dadimashtaka Churna is effective in the management of Agnimandya. |
assessment on 0th, 8th, 15th,21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bruhad Dadimashtaka Churna is better than Hingwashtaka churna in the management of Agnimandya. |
assessment on 0th, 8th, 15th,21st day |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is randomized, parallel group ,this trial comparing the efficacy of Bruhad Dadimashtaka churna 2 gm in saman kaal with Hingwashtaka churna for 14 days and next 7 days Observation.21 days treatment protocol. all the diseases are caused mainly due to agnimandya. thus to prevent progression it is necessary to cure it at early stage. Agnimandya has a main step occurring in pathogenesis of many diseases like jwara, arsha, grahani, atisar, ajeerna, pandu, gulma, kamala, shotha, shwasa. Due to decrease in the intensity of agni, the apachit ahara - rasa is produced leading to strotorodha and ama nirmiti. Hence while treating any disease, samprapti bhanga should be done with initiation of amapachana and agnivardhan chikitsa to get fast and complete cure. Brhuhad Dadimashtaka Churna has properties like deepana and pachana with Katu, Tikta rasa ,Katu Vipak, Ushna Virya , Laghu, Ruksha ,Tikshana Guna, thus it stimulates the agni and improves the digestion. Ayurveda Samhita has described many herbs that work on agnimandya i have selected Bruhad Dadimashtaka churna which is explained in sharangdhar samhita madhyamkhanda 6th prakarana, churnakalpana. The drug is easily available, easily palatable and economical. |