CTRI/2023/06/053939 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On:
14/06/2023
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda Other (Specify) [curative]
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Comparative Clinical Study To Evaluate The Efficacy Of Chaturbhadra Kwath With Panchamrita Parpati Vati In The Management Of Grahani.
Scientific Title of Study
Randomized Controlled Comparative Clinical Study To Evaluate The Efficacy Of Chaturbhadra Kwath With Panchamrita Parpati Vati In The Management Of Grahani.
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 Aishwarya Karandikar
Designation
PG Scholar, Kayachikitsa
Affiliation
Dr D. Y. Patil University, School of Ayurveda
Address
1st floor,OPD no.01,Deparment of Kayachikitsa, Block no.10, Dr D. Y. Patil University, School of Ayurveda,Sector 7, Nerul, Navi Mumbai
Thane MAHARASHTRA 400706 India
Phone
9819639895
Fax
Email
karandikaraishwarya@gmail.com
Details of Contact Person Scientific Query
Name
Dr Ashish Mhatre
Designation
Associate Professor, Department of Kayachikitsa
Affiliation
Padmashri Dr D. Y. Patil University, School of Ayurveda
Address
1st floor,OPD no.01,Deparment of Kayachikitsa,Block no.10, Dr D. Y. Patil University, School of Ayurveda,Sector 7, Nerul, Navi Mumbai
Thane MAHARASHTRA 400706 India
Phone
9819639895
Fax
Email
ashishmhatre2010@gmail.com
Details of Contact Person Public Query
Name
Dr Ashish Mhatre
Designation
Associate Professor, Department of Kayachikitsa
Affiliation
Padmashri Dr D. Y. Patil University, School of Ayurveda
Address
1st floor,OPD no.01,Deparment of Kayachikitsa,Block no.10, Dr D. Y. Patil University, School of Ayurveda,Sector 7, Nerul, Navi Mumbai
Thane MAHARASHTRA 400706 India
Phone
9819639895
Fax
Email
ashishmhatre2010@gmail.com
Source of Monetary or Material Support
DY Patil School of Ayurveda,DY Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai 400706
Primary Sponsor
Name
Dr Aishwarya Karandikar
Address
DY Patil School of Ayurveda,DY Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai 400706
Type of Sponsor
Other [Self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Aishwarya Karandikar
DY Patil School of Ayurveda
1st floor,OPD no.01,Deparment of Kayachikitsa, Block no.10, Dr D. Y. Patil University, School of Ayurveda,Sector 7, Nerul, Navi Mumbai Thane MAHARASHTRA
9260186212
karandikaraishwarya@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
The Institutional Ethics Committee of School of Ayurveda D.Y.Patil Deemed to be University
Clinically diagnosed patients fulfilling the subjective criteria of Grahanidosha. Muhur Baddha,
Muhur Drava Mala Pravritti, Aruchi, Udarshool, Prasek, Udgara Pravritti, Trishna, Arochak,
Vidaha, Pada Shoth, Aalasya, Tama Pravesh, Balakshaya, Chardi.
ExclusionCriteria
Details
Patients suffering from acute diarrhoea, intestinal tuberculosis, ulcerative colitis, gastric and
peptic ulcer, strictures, colonic cancer, toxic mega colon, pregnancy, haemorrhage , perforation,
immune-compromised, uncontrolled diabetes.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Relief from the subjective assessment criteria i.e clinical signs and symptoms of Grahani like Muhur Baddha/Muhur Drava Mala pravritti, Mala Swaroop, Udgara Pravritti, Trishna, Arochaka, Vidaha, Pada Shoth, Aalasya,Tama Pravesh, Prasek, Bala Kshay and Chardi.
The outcome will be assessed at baseline, 15th day and 30th day
Secondary Outcome
Outcome
TimePoints
Nil
Nil
Target Sample Size
Total Sample Size="100" Sample Size from India="100" 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 3
Date of First Enrollment (India)
26/06/2023
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="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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
Brief Summary
TITLE OF DISSERTATION - RANDOMIZED CONTROLLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHATURBHADRA KWATH WITH PANCHAMRITA PARPATI VATI IN THE MANAGEMENT OF GRAHANI
AIM AND OBJECTIVES: Aim: To Evaluate The Efficacy of Chaturbhadra Kwath with Panchamrita Parpati Vati In The Management Of Grahani.
Objectives: 1] To evaluate the efficacy of Chaturbhadra Kwath in the management of Grahani.
2] To evaluate the efficacy of Panchamrita Parpati Vati in the management of Grahani.
3]To compare the efficacy of Chaturbhadra Kwath with Panchamrita Parpati Vati in the Management of Grahani.
RESEARCH QUESTION-
Primary Research Question: - Is Chaturbhadra Kwath effective in the management of Grahani?
Secondary Research Question: - Is the effect of Chaturbhadra Kwath significant than Panchamrita Parpati Vati in the management of Grahani?
HYPOTHESIS:
H0: There will be no significant effect of Chaturbhadra Kwath than Panchamrita Parpati Vati in management of Grahani.
H1: There will be significant effect of Chaturbhadra Kwath than Panchamrita Parpati Vati in management of Grahani.
DIAGNOSTIC CRITERIA:- • The parameters for diagnosis are completely based on classical signs and symptoms like Muhur Baddha and Muhur Drava Mala Pravritti, Aruchi, Udarshoola, Prasek, Udgara Pravrutti, Trishna, Arochak,Videha, Pada Shoth, Aalasya, Tama Pravesh, Bala Kshay and Chardi. • Assessment of Agni • Blood investigation (CBC, LFT, Sr.Creatinine, BSL- F, PP) • Stool Examination Routine and Microscopic • Urine examination Routine and Microscopic
MATERIALS Group A (ChaturbhadraKwath)- Shunthi, Guduchi, Ativisha, Musta
SOP OF PREPARATION OF CHATURBHADRA KWATH:- Raw material for Chaturbhadra Kwath will be purchased from authentic pharmaceutical company. The raw materials will be identified and authorized by Department of Dravya Guna, D.Y.Patil Deemed to be University, School of Ayurveda. According to the procedure mentioned in Sharangdhar Samhita, One pala of each coarsely powdered drugs will be boiled with 16 parts of water over mild flame till the liquid is reduced to 1/8th of the original quantity. The Chaturbhadra Kwath will be formed in the terms of Syrup through authentic GMP certified company.
DOSE: Chaturbhadra Kwath 40 ml BD
GROUP B (Panchamrita Parpati Vati): - Shuddha Parad, Shuddha Gandhak, Abhrak Bhasma, Loha Bhasma, Tamra Bhasma
SOP OF PREPARATION OF PANCHAMRITA PARPATI VATI:- Panchamrita Parpati will be prepared at Rasashala, a G.M.P certified pharmaceutical company from Pune. The reference used for this preparation is from Rasendra Sara Sangraha. Firstly, Kajjali will be prepared by rubbing mercury with sulphur in a khalva (mortar).Other ingredients will be incorporated,blended thoroughly and heated over mild flame. The molten liquid will be pressed between the Kadali leaves one with cow-dung bolus and other spreaded over cow dung platform. These thin flakes will be collected, made into fine powder and then tablets will be formed.Tablet will be made by tablet punching machine.
DOSE: Panchamrita Parpati Vati 250 mg BD (125 mg each tablet) with Koshna Jala
ASSESSMENT CRITERIA-
All the signs ans symptoms of Grahani as mentioned by Acharya Charak will be assessed before and after treatment.
Symptoms are-
1.MuhurBaddha / Muhur Drava Mala Pravritti
2.Mala Swaroop
3. Udgara Pravritti
4. Trishna
5. Arochaka
6. Vidaha
7. Pada Shoth
8. Aalasya
9.Tama Pravesha
10. Prasek
11. Bala Kshaya
12. Chardi
STATISTICAL ANALYSIS: Efficacy of Subjective criteria will be analysed by Wilcoxon signed rank test, Efficacy of Objective criteria will be analysed by student paired t-test, Subjective parameters in between group will be compared by Mann Whitney U Test, Objective parameters in between the groups will be compared by Unpaired t-test.
DISCUSSION AND CONCLUSION: Discussion, Conclusion & Summary will be prepared based on result found