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CTRI Number  CTRI/2026/02/103378 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 07/03/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Post Marketing Surveillance of Amlapitta Mishran Suspension in Functional dyspepsia A Prospective Multicenter Study 
Scientific Title of Study   Prospective, open label, multicenter, single arm, post marketing surveillance study for evaluation of safety and efficacy of Amlapitta Mishran Suspension in participants diagnosed with Amlapitta (Functional dyspepsia) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anaya Pathrikar 
Designation  Professor, (B.A.M.S., M.D. (Kayachikitsa), Ph.D.) 
Affiliation  Seth R.V. Ayurved Hospital, Sion (E), Mumbai 
Address  Department of Kayachikitsa Ayurvidya Prasarak Mandal’s Seth R. V. Ayurved Hospital and V. M. Charitable Outpatient Department (OPD)

Mumbai
MAHARASHTRA
400022
India 
Phone  9870214595  
Fax    
Email  anayapathrikar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh B Chawda 
Designation  Senior Manager - Medical Services 
Affiliation  Shree Dhootapapeshwar Limited 
Address  135, Nanubhai Desai Road, Khetwadi, Mumbai - 400 004

Mumbai
MAHARASHTRA
400 004
India 
Phone  9821482290  
Fax    
Email  mbc@solumiks.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh B Chawda 
Designation  Senior Manager - Medical Services 
Affiliation  Shree Dhootapapeshwar Limited 
Address  135, Nanubhai Desai Road, Khetwadi, Mumbai - 400 004

Mumbai
MAHARASHTRA
400 004
India 
Phone  9821482290  
Fax    
Email  mbc@solumiks.in  
 
Source of Monetary or Material Support  
Shree Dhootapapeshwar Limited 
 
Primary Sponsor  
Name  Shree Dhootapapeshwar Limited 
Address  135, Nanubhai Desai Road, Khetwadi, Mumbai - 400 004 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 68  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vaidya Sharvari Dipak Abhyankar   121 Ayurved – Dispensary and Panchakarma Clinic  121 Ayurved – Dispensary and Panchakarma Clinic
Mumbai
MAHARASHTRA 
9820099710

sharvari.dipak@gmail.com 
Vaidya Swati Dinesh Jawalikar   Aarogyved Clinic  Shop No. 22 Gaytri Darshan Next to Hotel Suruchi Thakur Complex Kandivali East Mumbai
Mumbai
MAHARASHTRA 
9820279259

vaidya.swati@yahoo.co.in 
Vaidya Praphul Meghaji Vikmani   Amrut Ayurvediya Aushadhalay  Shop No. 9, Gupta Bhuvan, Opp. Railway Station, Mulund West, Mumbai 400080
Mumbai
MAHARASHTRA 
9821746871

drpraphulmv@gmail.com 
Vaidya Ashwini Rameshwar Mhamane  Ariv Ayurveda  Near Jain Mandir Kabutar Khana Dadar W Mumbai 400028
Mumbai
MAHARASHTRA 
7303732270

ashwini1983mhamane@gmail.com 
Vaidya Kirti Narendra Tare   Arogyam Holistic Wellness Clinic  Emerald Plaza, Block Number 3, Shop Number 114, First Floor, Besides Kashinath Ghanekar Auditorium, Gladys Alwares Road, Thane West 400610
Thane
MAHARASHTRA 
9004686497

kirtint@gmail.com 
Vaidya Mrs Pradnya Nitin Aptikar   Arya Clinic  Laxmi Vilas Building RBL Bank Lane, Near Ghantali Devi Mandir, Naupada, Thane (West) 400602, Maharashtra
Thane
MAHARASHTRA 
9820492902

pradnyaaptikar@gmail.com 
Vaidya Narendra Shrihari Kadhe   Atharva Ayurved Chikitsalaya and Panchakarma Kendra  Shop No.5, Dhairya Society, S.V. Road, Bhaskar Colony, Naupada, Thane W 400602
Thane
MAHARASHTRA 
9869572951

nskadhe@gmail.com 
Vaidya Hema Kadam Barade   Atharva Ayurvedic Clinic  Shop 2 and 3 Maruti Darshan Plot 19, Sector 6, Kamothe Navi Mumbai - 410209
Raigarh
MAHARASHTRA 
7715002540

vdhemakadam@gmail.com 
Vaidya Jayashree Medhekar   Aujas Ayurvedalay  Anna Saheb Patil Rahiwashi Sakhntana EWS NL 1A, 42 06 Shop Ground Floor Sec 10 Nerul West Navi Mumbai Thane 400706, Maharashtra
Thane
MAHARASHTRA 
8652105050

jayamadhekar@gmail.com 
Dr Anaya Pathrikar  AVPMs Seth R. V. Ayurved Hospital and V. M. Charitable Outpatient Department (OPD)  Department of Kayachikitsa Seth R.V. Ayurved Hospital, Sion (E), Mumbai - 400 022.
Mumbai
MAHARASHTRA 
9870214595

anayapathrikar@gmail.com 
Vaidya Snehal Yogesh Jagdale   Ayu Care Clinic and Panchkarma Centre   A1 Mohata Nagar CHS Behind St Josephs School Vikhroli West 400079
Mumbai
MAHARASHTRA 
9769210718

snehal.j1311@gmail.com 
Vaidya Asma Inamdar   Ayucare Ayurvedic Clinic and Panchkarma Centre  Sector 16 Vashi Navi Mumbai, Near Shivshani Mandir Vashi 400703
Thane
MAHARASHTRA 
9975552231

dr.aasma_inamdar@yahoo.com 
Vaidya Rutuja Kartik Trivedi   Ayurtech Ayurvedic Clinic  M. G. Road, Opp. Ghandhi Market, Ghatkopar East, Mumbai 400077
Mumbai
MAHARASHTRA 
9373879209

rutu2dec1985@gmail.com 
Vaidya Amruta Welankar Kamtekar   Deerghayu Panchakarma and Cosmetic Clinic   First Floor Sairam Building Milap Nagar MIDC Dombivli East Above Jaganath Store and Jagruti Sweet Mart 421203
Thane
MAHARASHTRA 
8879756788

deerghayuchikitsalaya07@gmail.com 
Vaidya Ketki Sanjay Ranade   Dhanvantari Chikitsalay  Flat No. 103, Raut CHS, Mental Hospital Rd, Thane W 400604
Thane
MAHARASHTRA 
9920037392

ksranade@yahoo.co.in 
Vaidya Prajakta Sourabh Apte   Dhanvantari Panchakarma Chikitsalay  Vitthal Mandir Compound, Thane w 400601
Thane
MAHARASHTRA 
9029190671

prajaktaparanjape@gmail.com 
Vaidya Swarupa Kulkarni   Dr. Swarupas Ayurvedic Clinic and Panchkarm Center  Shop No. 4, Vasant Villa, Andheri Sahar Road. Andheri East Mumbai 400069
Mumbai
MAHARASHTRA 
9833464049

satishswarupa@yahoo.co.in 
Vaidya Manasi Paras Gandhi   Gandhi Clinic  Shop No 9, B-Blue Diamond, C.S. Road No. 4, Anand Nagar, Dahisar East, Mumbai 400068
Mumbai
MAHARASHTRA 
9820518850

dr.manasigandhi@gmail.com 
Vaidya Kiran Pandit   Gurukrupa Hospital  2nd Floor, Opp S T Workshop, Khopat, Thane (West) 400601
Thane
MAHARASHTRA 
9821090696

drkiranpandit@gmail.com 
Vaidya Sampada Kiran Pandit   Gurukrupa Hospital  2nd Floor, Opp. S T Workshop, Khopat, Thane West 400601
Thane
MAHARASHTRA 
9322216168

drsampadapandit@gmail.com 
Vaidya Shalini Abhijit Dhamne   Megha’s Ayurworld  Shivai Nagar, Near Gajanan Maharaj Mandir, Thane W 400606
Thane
MAHARASHTRA 
9167622637

shalini.dhamne.sd@gmail.com 
Vaidya Vinaya Vinay Londhe   Niramay Ayurved Chikitsalay and Panchakarma Center  Building No. 157 Room No. 4845, First Floor, Kannamwar Nagar 1, Vikhroli East, Mumbai 400083
Mumbai
MAHARASHTRA 
9819817050

lvv231@gmail.com 
Vaidya Pallavi Harshal Shendurnikar   Ojus Ayurved and Panchakarma Clinic   Shop No. 55 C and D Wing Vardhaman Vatika Opposite Kolshet D Mart Thane W 400607
Thane
MAHARASHTRA 
9819131789

pallavi.shendurnikar@gmail.com 
Vaidya Arpita Kajrekar   Panchtatwa Panchkarma Centre  F 12 Vrushali Shilp, Diagonally Opposite Hotel Banana Leaf, Chikuwadi Link Road, Borivali West, Mumbai 400 092
Mumbai
MAHARASHTRA 
9076318190

arpitakajrekar74@gmail.com 
Vaidya Sampada Khanvilkar   Plaza Ayurveda Bhandar  Shop No 5, Bhalchandra Krupa Bldg, Manpada Rd, Near Shirodkar Hospital, Dombivli 421201, Maharashtra
Thane
MAHARASHTRA 
9619629720

khanvilkarsampada95@gmail.com 
Vaidya Aruna Hemant Tilak   Poorna Clinic   Shop No 7, Shri Saishradha Society, Waghbil Naka Ghodbundar Road, Thane West 400615
Thane
MAHARASHTRA 
9821478884

arunatilak@gmail.com 
Vaidya Avanti Chalke   Punarvasu Chikitsalaya  Shop No. 2, Yashshree Plaza, Sector 8, Near 7th Day High School, Sanpada, Navi Mumbai 400705
Thane
MAHARASHTRA 
8655769869

vdavantichalke.09@gmail.com 
Vaidya Prashant Prabhakar Waghmare   Punarvasu Chikitsalaya  Shop No. 2, YashShree Plaza, Sector 8, Near 7th Day High School, Sanpada, Navi Mumbai 400705
Thane
MAHARASHTRA 
9867888265

vdppwaghmare@gmail.com 
Vaidya Shrikant Bajarang Sanmukh   Samhita Ayurved and Panchkarm Chikitsalay  Shop No. 7, Bldg. No. 6, Jai Santoshi Maa CHS., Gauri Shankar Wadi No. 2, Pant Nagar, Ghatkopar East, Mumbai 400075
Mumbai
MAHARASHTRA 
9967766840

vd.shreekant@gmail.com 
Vaidya Pallavi Hitendra Bhirud   SAYO Ayurvedic Clinic & Panchakarma Center   Shop No 9, Tirupati Icon, Plot No 4 or 5. Sector 20, Kamothe, Navi Mumbai 410209
Raigarh
MAHARASHTRA 
8082558972

pallavibhirud@gmail.com 
Vaidya Megha Nijai   Sharvani Ayur Multispecialty Ayurveda Clinic and Panchakarma Centre  Shop No 7, Herambh Sankul Society Opp TMC Office Uthalsar Thane West 400601
Thane
MAHARASHTRA 
9594966388

sharvaniayur@gmail.com 
Vaidya Manisha Gharad   Shatayu Ayurveda Panchakarma Centre and Clinic  Sector 19 Kamothe Near Poddar Jumbo Kids School 410209
Raigarh
MAHARASHTRA 
9320902784

manishachikhale09@rediffmail.com 
Vaidya Priti Prashant Dhake   Shatayusshi Ayurved and Panchakarma Kendra  1, Moksh Mahal, P. K. Road, Mulund W, Mumbai 400080
Mumbai
MAHARASHTRA 
9869377162

drpritidhake@gmail.com 
Vaidya Apurva Limaye Phadke  Shivam Polyclinic  Above Mango, Gokhale Road, Naupada, Thane W 400602
Thane
MAHARASHTRA 
8888335032

dr.apurvaphadke25@gmail.com 
Vaidya Meenal Deepak Badwe   Shree Ayurved and Panchakarma Centre  101, Pushkaraj Praasad, Bajiprabhu Deshpande Road, Near Bedekar Marathi School, Naupada, Thane West 400602
Thane
MAHARASHTRA 
9322161744

drmeenalbadwe@hotmail.com 
Vaidya Madhav Bhagwat   Shree Dhanvantari Ayurvedic Clinic  Atharva CHS, Behind Gaondevi Mandir, Kalwa West 400605
Thane
MAHARASHTRA 
8454919417

drm.bhagwat78@gmail.com 
Vaidya Sangita Pravin Shete   Shree Krishna Clinic  New Happy Home C.H.S, Flat No. 1, Plot No. 3, Sector 48, Seawoods W, Navi Mumbai 400706
Thane
MAHARASHTRA 
9819072328

drsangitashete453@gmail.com 
Vaidya Kiran Sadashiv Kalyankar   Shree Vishwa-Ganesh Ayurveda & Panchakarma Clinic  Shree Vishwa-Ganesh Ayurveda & Panchakarma Clinic, Kharghar
Thane
MAHARASHTRA 
8898630831

dr.kirankalyankar@gmail.com 
Vaidya Deepti Dandekar   Shree Vishwachakshu Ayurvediya Chikitsalay  Shop No. 1, C Wing, Yugandhar Sudama CHS, Behind Blackberry Store, Opp. Nana Nani Park, Near Gaondevi Mandir, Manpada Road, Dombivali E 421201
Thane
MAHARASHTRA 
9987005997

dipti.nene@gmail.com 
Vaidya Pratibha Shailesh Hinge   Shree Vishwadhanva Ayurved and Panchakarma Center  1, Popular Niketan, 73 C, S. H. Paralkar Road, Shivaji Park, Dadar W, Mumbai 400028
Mumbai
MAHARASHTRA 
7977067299

vishwadhanvayurved@gmail.com 
Vaidya Nitin Hanumant Thorat   Shri Vishwatej Ayurved Research Hospital  Shop No. 4, 5 & 6, Pushp Corner Society, Plot Number 76, 77, Sector 12, Near Krishna Hotel Kamothe Navi Mumbai 410209
Raigarh
MAHARASHTRA 
9867980769

shri.vishwatej9423@gmail.com 
Vaidya Kalpesh Khairnar   Shripad Ayurveda Chikitsalaya  Eden Park, New Panvel 410206
Raigarh
MAHARASHTRA 
9890641628

shripadayurved@gmail.com 
Vaidya Prajakta Rajurkar   Spandan Ayurved  B 101, New Laxmi Sadan, Opp. Thakur Public School, Above Indian Bank, Thakur Village Kandivali East Mumbai 400101
Mumbai
MAHARASHTRA 
9930625567

Prajakta.vasekar@gmail.com  
Vaidya Madhumita Mohan Paranjape  Sri Samvardhan Ayurveda and Acupuncture Clinic  5, Hemprabha Society, Sudarshan Colony, Thane E 400603
Thane
MAHARASHTRA 
9967480342

madhumitaparanjape@gmail.com 
Vaidya Pratik Pushkarbhai Joshi   Surgived Clinic  Shop No 11, Om Sai Shravan Building, Near Shimpoli Telephone Exchange, Borivali West, Mumbai 400092
Mumbai
MAHARASHTRA 
9930384898

drpratik17joshi@gmail.com 
Vaidya Kirti Mandar Deo   Swakrut Clinic  502, Laxmi Palace CHS, M.G. Road, Near Godbole Hospital, Naupada, Thane (West), Maharashtra 400602
Thane
MAHARASHTRA 
9820286429

vaidyakirti.deo@gmail.com 
Vaidya Gayatri Makarand Joshi   Swasthyam Panchkarma Center  Shop 3, Someshwar Apt. Dharmveer Marg, Pachpakhadi, Thane West 400602
Thane
MAHARASHTRA 
9819648386

swasthyam4everyone@gmail.com 
Vaidya Alekha Ashwin Chorghe   Vaidya Alekha Chorghes Clinic  38 C, Sarvodaya Bhuvan, Gokhale Road North, Dadar West, Mumbai 400028
Mumbai
MAHARASHTRA 
9004902787

dralekhamum@gmail.com 
Vaidya Aparna Dnyanesh Raut   Vaidya Aparna Rauts Clinic  2, Sankalp, Plot No. 1040, Off Sayani Road, Prabhadevi, Mumbai 400025
Mumbai
MAHARASHTRA 
9819221911

Adie.ayurveda@gmail.com 
Vaidya Bharti Ajay Deshpande   Vaidya Bharti Deshpandes Clinic  Shop Number 430, Lodha Signet, Kolshet Rd, Kolshet Industrial Area, Thane w, Thane, Maharashtra 400607
Thane
MAHARASHTRA 
9819795860

bhartiadeshpande@gmail.com 
Vaidya Chhaya Ranjeet Dhawad   Vaidya Chhaya Dhawads Clinic  1101, Monarch Fortune Sec-18 Plot 19 Kharghar Navi Mumbai
Thane
MAHARASHTRA 
9867379302

anjali.dhawad@gmail.com 
Vaidya Dhanashree Karmarkar   Vaidya Dhanashree Karmarkars Clinic  503, Vijay Tower, Dr. Lazurus Road, Near Dagadi Shala, Charai, Thane West
Thane
MAHARASHTRA 
9309969114

dhanashreekarmarkar23@gmail.com 
Vaidya Jyoti Jadhav   Vaidya Jyoti Jadhavs Clinic  J 504, Haware Splendor, Plot No.56, Sector 20, Khargar, Navi Mumbai 410210
Thane
MAHARASHTRA 
7039205691

jjjsjadhav4@gmail.com 
Vaidya Karuna Shekhar Lad   Vaidya Karuna Lads Clinic  Shop No 01, Trimurti Tower, Plot B 90, Nerul East Navi Mumbai 400706
Thane
MAHARASHTRA 
9833174574

drkarunalad@gmail.com 
Vaidya Mangesh Harsing Patil   Vaidya Mangesh Patils Clinic   191, Pawai Chowk, Near Panchratan Mandir Hariyana Handloom Shop, Mulund Colony, Mulund West, Mumbai 400082
Mumbai
MAHARASHTRA 
9820597253

drmangesh1975@gmail.com 
Vaidya Namrata Prakash Goray   Vaidya Namrata Gorays Clinic   101, Bhagwan Krishna Niwas, Gavand Path, Bhaskar Colony, Naupada, Thane West 400602
Thane
MAHARASHTRA 
8454049108

namratagoray@gmail.com 
Vaidya Preeti Dilip Lokhande   Vaidya Preeti Dilip Lokhandes Clinic  302, Monterossa, 90 Ft Road, Near Siddhivinayak Mandir, Above IDFC First Bank, Ghatkopar (East), Mumbai 400075
Mumbai
MAHARASHTRA 
9833002740

dr.preetilokhande@gmail.com 
Vaidya Priyanka Sameer Kodkani   Vaidya Priyanka Kodkanis Clinic  A35 Kirti CHS, Jijamata Road, Kopri, Thane East 400603
Thane
MAHARASHTRA 
9029087286

priyanka.kodkani@gmail.com 
Vaidya Rakhee Raghuvir Rathod   Vaidya Rakhee Rathods Clinic  Shop No.2, Building No.28, Beside Canara Bank, Nehru Nagar, Kurla E, Mumbai 400024
Mumbai
MAHARASHTRA 
7208131630

rakhirathod100@gmail.com 
Vaidya Rekha Bhuimbar   Vaidya Rekha Bhuimbars Clinic  Shop No 1, Parshwanath Galaxy, Ghodbunder Road, Kasarwadavali, Thane W 400615
Thane
MAHARASHTRA 
7304129623

drrekhabhuimbar@yahoo.com 
Vaidya Rekha Mahadev Gidde   Vaidya Rekha Giddes Clinic   B 602, Nature Glory Phase 2, Parsik Nagar, Kalwa West, Thane 400605
Thane
MAHARASHTRA 
9892602559

dr.rekhagiddejadhav@gmail.com 
Vaidya Satish Sawale   Vaidya Satish Sawales Clinic  Office No.10, Plot No.23, Sector 8, Nerul 400 706
Thane
MAHARASHTRA 
9320047224

sawalesatish@gmail.com 
Vaidya Shruti Joshi Pathak   Vaidya Shruti Joshis Clinic  A/903 Shree Satya Shankar Residency, Near Neelkanth Greens, Manpada, Ghodbunder Road, Thane West 400607
Thane
MAHARASHTRA 
7304729054

shrutijsh29@gmail.com 
Vaidya Shweta Shashikant Deshpande   Vaidya Shweta Deshpandes Clinic  101 Bali Tower, Station Road Kalwa West 400605
Thane
MAHARASHTRA 
9773415636

drshwetadeshpande1@gmail.com 
Vaidya Swamini Santosh Bane   Vaidya Swamini Banes Clinic  4 Shivraj Apts., Near Siddheshwar Ram Mandir, Hansnagar, Khopat, Thane 400601
Thane
MAHARASHTRA 
9619531811

drswaminibane@gmail.com  
Vaidya Swati Shardul Karve   Vaidya Swati Karves clinic  C1 604, Rutu Park, Near Vrundavan Bus Terminal, Majiwada Thane W 400601
Thane
MAHARASHTRA 
9819017164

skarve03@gmail.com 
Vaidya Pragati Yerwankar  Vedang Clinic  Shree Pandurang Apt, Sector 44A Seawoods Navi Mumbai
Thane
MAHARASHTRA 
9860120368

pragati_y@yahoo.com 
Vaidya Rina Dethe   Vishwasaukhya Ayurved  B2 27 9, B2 Type Owners Association, Near Ganga Tower, Sec 16, Vashi 400703
Thane
MAHARASHTRA 
9004364072

rinapande@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 69  
Name of Committee  Approval Status 
121 Ayurved – Dispensary and Panchakarma Clinic  No Objection Certificate 
Aarogyved Clinic   No Objection Certificate 
Amrut Ayurvediya Aushadhalay  Submittted/Under Review 
Ariv Ayurveda  No Objection Certificate 
Arogyam Holistic Wellness Clinic  No Objection Certificate 
Arya Clinic  No Objection Certificate 
Atharva Ayurved Chikitsalaya and Panchakarma Kendra  No Objection Certificate 
Atharva Ayurvedic Clinic   No Objection Certificate 
Aujas Ayurvedalay  No Objection Certificate 
Ayu Care Clinic and Panchkarma Centre   No Objection Certificate 
Ayucare Ayurvedic Clinic and Panchkarma Centre  No Objection Certificate 
Ayurtech Ayurvedic Clinic  No Objection Certificate 
Ayurvida Prasarak Mandal IEC  Approved 
Deerghayu Panchakarma and Cosmetic Clinic   No Objection Certificate 
Dhanvantari Chikitsalay  No Objection Certificate 
Dhanvantari Panchakarma Chikitsalay  No Objection Certificate 
Dr. Swarupas Ayurvedic Clinic and Panchkarm Center  No Objection Certificate 
Gandhi Clinic  No Objection Certificate 
Gurukrupa Hospital  No Objection Certificate 
Gurukrupa Hospital  No Objection Certificate 
Megha’s Ayurworld  No Objection Certificate 
Niramay Ayurved Chikitsalay and Panchakarma Center  No Objection Certificate 
Ojus Ayurved and Panchakarma Clinic   No Objection Certificate 
Panchtatwa Panchkarma Centre  No Objection Certificate 
Plaza Ayurveda Bhandar  No Objection Certificate 
Poorna Clinic  No Objection Certificate 
Punarvasu Chikitsalaya  No Objection Certificate 
Punarvasu Chikitsalaya  No Objection Certificate 
Samhita Ayurved and Panchkarm Chikitsalay  No Objection Certificate 
SAYO Ayurvedic Clinic & Panchakarma Center  No Objection Certificate 
Seth R. V. Ayurved Hospital, Sion Mumbai  No Objection Certificate 
Sharvani Ayur Multispecialty Ayurveda Clinic and Panchakarma Centre  No Objection Certificate 
Shatayu Ayurveda Panchakarma Centre and Clinic  No Objection Certificate 
Shatayusshi Ayurved and Panchakarma Kendra  No Objection Certificate 
Shivam Polyclinic  No Objection Certificate 
Shree Ayurved and Panchakarma Centre  No Objection Certificate 
Shree Dhanvantari Ayurvedic Clinic  No Objection Certificate 
Shree Krishna Clinic  No Objection Certificate 
Shree Vishwa-Ganesh Ayurveda & Panchakarma Clinic  No Objection Certificate 
Shree Vishwachakshu Ayurvediya Chikitsalay  No Objection Certificate 
Shree Vishwadhanva Ayurved and Panchakarma Center  No Objection Certificate 
Shri Vishwatej Ayurved Research Hospital  No Objection Certificate 
Shripad Ayurveda Chikitsalaya  No Objection Certificate 
Spandan Ayurved  No Objection Certificate 
Sri Samvardhan Ayurveda and Acupuncture Clinic  No Objection Certificate 
Surgived Clinic  No Objection Certificate 
Swakrut Clinic  No Objection Certificate 
Swasthyam Panchkarma Center  No Objection Certificate 
Vaidya Alekha Chorghes Clinic  No Objection Certificate 
Vaidya Aparna Rauts Clinic  No Objection Certificate 
Vaidya Bharti Deshpandes Clinic  No Objection Certificate 
Vaidya Chhaya Dhawads Clinic  No Objection Certificate 
Vaidya Dhanashree Karmarkars Clinic  No Objection Certificate 
Vaidya Jyoti Jadhavs Clinic  No Objection Certificate 
Vaidya Karuna Lads Clinic  No Objection Certificate 
Vaidya Mangesh Patils Clinic  No Objection Certificate 
Vaidya Namrata Gorays Clinic  No Objection Certificate 
Vaidya Preeti Lokhandes Clinic  No Objection Certificate 
Vaidya Priyanka Kodkanis Clinic  No Objection Certificate 
Vaidya Rakhee Rathods Clinic  No Objection Certificate 
Vaidya Rekha Bhuimbars Clinic  No Objection Certificate 
Vaidya Rekha Giddes Clinic  No Objection Certificate 
Vaidya Satish Sawales Clinic  No Objection Certificate 
Vaidya Shruti Joshis Clinic  Submittted/Under Review 
Vaidya Shweta Deshpandes Clinic  No Objection Certificate 
Vaidya Swamini Banes Clinic  No Objection Certificate 
Vaidya Swati Karves Clinic  No Objection Certificate 
Vedang Clinic  No Objection Certificate 
Vishwasaukhya Ayurved  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Amlapitta Mishran Suspension, Reference: NA, Route: Oral, Dosage Form: Dravaka, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: Amlapitta Mishran Suspension, Reference: NA, Route: Oral, Dosage Form: Dravaka, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: Amlapitta Mishran Suspension is available in the Indian market for over 20 years
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants of either sex in the age group of 18 to 65 years.
2. Presence of Amlapitta, as diagnosed by the Amlapitta Symptom Rating Scale (ASRS) more than or equal to 5 [with Tikta Amla Udgaar (Sour and bitter belching) and Hrit Kantha Daha (Burning Sensation) Score more than or equal to 1] who have been prescribed Amlapitta Mishran Suspension.
3. Participants willing to give written informed consent.
4. Participants willing to follow up. 
 
ExclusionCriteria 
Details  1. Pregnant or lactating women based on history.
2. Participants who received Amlapitta Mishran Suspension within 30 days prior to study.
3. Participants with documented H. pylori infection.
4. Participants with documented or verbal history of chronic uncontrolled disorders including hepatic, renal or endocrine diseases.
5. Participants with previous allergic reactions to any components of Amlapitta Mishran Suspension.
6. Participants with history of gastrointestinal tract malignancy.
7. Participants administered with H2 receptor antagonists (like Famotidine, and Cimetidine), muscarinic receptor antagonists (like Mebeverine, Dicyclomine, and Clidinium bromide), proton pump inhibitors (like Omeprazole, Pantoprazole, and Rabeprazole), prostaglandins (like Misoprostol) or mucosal protective agents (like Sucralfate) within 1 week prior to study.
8. Participants taking other investigational drugs within 30 days prior to the study.
9. Participants who are unable to provide informed consent, such as those suffering from mental disease, mental retardation, or unconsciousness.
10. Participants that Principal Investigator or Co-Principal Investigators consider ineligible for this study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the Amlapitta Symptom Rating Scale (ASRS) score compared to the baseline score. The definition of "improvement" is the participants showing reduction ratio of 50 percent or more in the score.  From baseline to day 6 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in the Postprandial Distress Syndrome (PDS) scale score compared to the baseline score
2. Change in the Epigastric Pain Syndrome (EPS) scale score compared to the baseline score 
From baseline to day 6 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   19/03/2026 
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="3"
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 - NO
Brief Summary  

Amlapitta can be correlated to acid peptic disorders like gastritis based on its symptomatology. Gastritis is a condition marked by inflammation, irritation, or erosion of the gastric mucosa. Gastritis is commonly treated based on signs and symptoms by medical practitioners and in majority of cases, they do not rely on endoscopies for diagnosis and treatment. Functional dyspepsia manifests as symptom complex of gastritis in the absence of abnormal endoscopic findings. i.e. endoscopy helps to differentiate gastritis from functional dyspepsia. Globally, about 10 to 30 percent adults suffer from functional dyspepsia. A study reports that 7.6 to 49 percent of Indian population suffers from dyspeptic symptoms. According to the recently revised Rome IV criteria, functional dyspepsia is defined by 1. Persistent or recurring dyspepsia for more than 3 months within the past 6 months; 2. No demonstration of a possible organic cause of the symptoms on endoscopy and 3. No sign that the dyspepsia is relieved only by defecation or of an association with stool irregularities. Functional Dyspepsia (FD) is divided into two subgroups according to cardinal symptoms namely, Postprandial Distress Syndrome (PDS) and Epigastric Pain Syndrome (EPS). The PDS subgroup is defined by symptoms triggered or aggravated by a meal, including postprandial fullness and early satiation and the EPS subgroup is characterized by meal unrelated symptoms, such as epigastric pain and epigastric burning. There can be overlapping PDS and EPS, which is characterized by meal induced dyspeptic symptoms and epigastric pain or burning. Modern medicine offers many drugs or medicaments for the management of Acid Peptic Disorders like gastritis, but their safety may be a cause of concern. Thus, there is need for a new drug with lower side effect profile and good efficacy. Ayurved the ancient Indian system of medicines is a rich database of herbal, mineral and animal origin raw materials or ingredients for the management of acid peptic disorders. 

The current study is planned to evaluate the efficacy and safety of Amlapitta Mishran Suspension in participants with Amlapitta (Functional dyspepsia). Amlapitta Mishran Suspension is widely used by Ayurved Practitioners across India in the management of Acid-Peptic Disorders. Amlapitta Mishran Suspension is documented for its anti-ulcer effect in experimental model of indomethacin induced gastric ulcers in rats. Amlapitta Mishran suspension effectively reduced endoscopic gastritis score in the participants and reduced the symptoms of gastritis measured by the Amlapitta Symptom Rating Scale (ASRS), PDS and EPS scores. Amlapitta Mishran Suspension was found to be a safe medication with no adverse events. Amlapitta Mishran Suspension offers the benefits of ingredients like Vasa (Adhatoda vasica), Guduchi (Tinospora cordifolia), Parpata (Fumaria indica), Nimba (Azadirachta indica), Kiratatikta (Swertia chirata), Bhrungaraja (Eclipta alba), Amalaki (Emblica officinalis), Haritaki (Terminalia chebula), Bibhitaka (Terminalia bellirica), Patola (Trichosanthes dioica), Yashti (Glycyrrhiza glabra), and Shouktik Bhasma (Processed Sea Shell).

 
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