| CTRI Number |
CTRI/2022/09/045986 [Registered on: 28/09/2022] Trial Registered Prospectively |
| Last Modified On: |
17/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL STUDY TO EXPLORE THE EFFECT OF RASA PRAYOG KRAMA SIDDHANT THAT IS BY USING TIKTA MADHUR KASHAY DRAVYS IN THIS SEQUENCE IN TREATMENT AMLAPIITA. |
|
Scientific Title of Study
|
Clinical study to explore rasa prayog krama siddhant in Pittaj vikar with special reference to Amlapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANALI DNYANESHWAR LAKADE |
| Designation |
MD SCHOLAR |
| Affiliation |
SUMATIBHAI SHAH AYURVED MAHAVIDYALA |
| Address |
DEPARTMENT OF DRAVYAGUNA, MAMs SUMATIBHAI SHAH AYURVED MAHAVIDYALA, MALWADI HADAPSAR, PUNE
Pune
MAHARASHTRA
411028
India |
| Phone |
8793757277 |
| Fax |
|
| Email |
manalilakade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHARAYU KORE |
| Designation |
HOD of DEPARTMENT OF DRAVYAGUNA |
| Affiliation |
SUMATIBHAI SHAH AYURVED MAHAVIDYALA |
| Address |
DEPARTMENT OF DRAVYAGUNA, MAMs SUMATIBHAI SHAH AYURVED MAHAVIDYALA, MALWADI HADAPSAR, PUNE
Pune
MAHARASHTRA
411028
India |
| Phone |
9970356590 |
| Fax |
|
| Email |
drkoresharayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MANALI DNYANESHWAR LAKADE |
| Designation |
MD SCHOLAR |
| Affiliation |
SUMATIBHAI SHAH AYURVED MAHAVIDYALA |
| Address |
DEPARTMENT OF DRAVYAGUNA, MAMs SUMATIBHAI SHAH AYURVED MAHAVIDYALA, MALWADI HADAPSAR, PUNE
Pune
MAHARASHTRA
411028
India |
| Phone |
8793757277 |
| Fax |
|
| Email |
manalilakade@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF DRAVYAGUNA VIGYAN, SANE GURUJI AROGYA KENDRA, MALWADI, HADAPSAR, PUNE 411028 |
|
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Primary Sponsor
|
| Name |
SANE GURUJI AROGYA KENDRA |
| Address |
SANE GURUJI AROGYA KENDRA , MALWADI,HADAPSAR, PUNE 411028 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MANALI LAKADE |
SANE GURUJI AROGYA KENDRA |
OPD NO.2 DEPARTMENT OF KAYACHIKITSA, SANE GURUJI AROGYA KENDRA, MALWADI, HADAPSAR, PUNE
Pune
MAHARASHTRA |
8793757277
manalilakade@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMS SUMATIBHAI SHAH AYURVED MAHAVIDYALAY AND SANE GURUJI AROGYA KENDRA |
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:K297||Gastritis, unspecified. Ayurveda Condition: AMLAPITTAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NIMBA, Reference: BHAVPRAKASH, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -KOSHNAJAL), Additional Information: -(2) Medicine Name: YASHTIMADHU, Reference: BHAVPRAKASH, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -KOUSHNAJAL), Additional Information: -(3) Medicine Name: ARJUN, Reference: BHAVPRAKASH, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -KOUSHNA JAL), Additional Information: - |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS PRESENTING WITH CLASSICAL SYMPTOMS OF SAMA AWASTHA OF AMLAPITTA.
|
|
| ExclusionCriteria |
| Details |
PREGNANT AND LACTATING WOMEN
PATIENT WITH NIRAM AWASTHA SYMPTOMS
PATIENT HAVING SERIOUS COMPLAINTS REGARDING GI BLEED, MALIGNANCY RELATED TO GASTROINTESTINAL TRACT
PATIENTS OF GRAHANI
PATIENTS WITH SEVERE VOMITING AND DIARRHEA
THOSE WHO CANT TAKE MEDICINES ORALLY
PATENT PRESENTING WITH HISTORY OF GASTRIC SURGERY. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| THE EFFECT OF RASA PRAYOG KRAMA BY USING TIKTA MADHUR AND KASHYA RASA DRAVYAS REDUCING SYMPTOMS OF AMLAPITTA WILL BE ASSESED. OBESERVATION OF THE PATIENTS AT REGULAR INTERVALS 0, 7, 14, 21 DAYS FOLLOW UP. THE SYMPTOMES WILL BE ASSESED ACCORDING TO THEIR SEVERITY AND RELIF SYMPTOMS WILL BE OBSERVED AFTER INTERVENTION. |
0th day, 7th day, 14th day, 21st day. Patient will be assessed on these days after giving intervention
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| TO CLINICALLY STUDY THE APPLICATION OF RASA PRAYOG KRAMA SIDDHANT IN AMLAPITTA. |
THE EFFECT OF DRUGS ACCORDING TO THEIR RASA THAT IS NIMBA IN 1ST 7 DAYS YASHTIMADHU FROM 8-14 DAYS AND ARJUN FROM 15 TO 21 DAYS IN AMLAPITTA WILL BE SEEN RESPECTIVELY |
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
CLINICAL STUDY TO EXPLORE RASA PRAYPOG KRAMA SIDDHANTA IN PITTAJ VIKAR WITH SPECIAL REFERENCE TO AMALAPITTA. IN THIS PILOT STUDY 20 PATIENTS OF AMLAPITTA WILL BE GIVEN INTERNAL MEDICATION ACCORDING TO THE AWASTHA OF AMLAPITTA DISORDER OVER 21 DAYS. THE PATIENTS FOR THIS STUDY WILL BE SELECTED PRESENTING WITH CLASSICAL SYMPTOMS OF AMLAPITTA. PATIENTS WILL BE ASSESSED FOR THE AWASTHA OF THE DISEASE AND ACCORDING TO THE PRESENTING AWASTHA , MEDICATION WILL BE GIVEN. IN THIS STUDY THE INTERNAL MEDICATION WILL BE GIVEN ACCORDING TO THE RASA PRAYOG KRAMA SIDDHANT , THAT IS THE MEDICATION WILL BE GIVEN ACCORDING TO THE RASA KRAMA IN PITTAJ VIKAR- TIKTA RASA MEDICINE, MADHUR RASA MEDICINE AND KASHAY RASA MEDICINE WILL BE GIVEN TO THE PATIENTS ACCORDING TO THEIR AWASTHA. TIKTA RASA- NIMBA CHOORNA MADHUR RASA-YASHTIMADHU CHOORNA KASHAY RASA- ARJUN CHOORNA RESPECTIVELY PATIENTS WILL BE ASSESED ON THE DAY OF ENROLLMENT FOLLWED BY 7TH DAY, 14TH DAY , 21ST DAY. ACHARYA KASHYAP HAS MENTIONED THE RASA PRAYOG KRAMA SIDDHANT IN TREATMENT OF DISEASE. THIS SIDDHANT EXPLAINS THE CHRONOLOGICAL USE OF RASA IN TREATMENT OF VARIOUS DISEASES. THIS SHOWS THE UNIQUENESS OF TREATING A DISEASE WITH SINGLE DRUG IN AYURVEDA. THIS KRAMA HELPS IN PACIFING VITIATED DOSHA AND GUNAS IN A SEQUENTIAL MANNER. |