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CTRI Number  CTRI/2025/08/093158 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Drakshavaleha  
Scientific Title of Study   “Effectiveness of Drakshavaleha in Improving the Symptoms of Functional Gastrointestinal Disorders(FGD) – A Multi-Centre Study” 
Trial Acronym  Effectiveness of Drakshavaleha 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Room no. 121,First floor, 61-65 Opposite to D Block, Institutional area, Janakpuri New Delhi

Central
DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Room No 121, , First Floor,61-65, Institutional Area, Opposite to D Block Janakpuri New Delhi


DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Room No 121, First Floor, 61-65 Opposite to D Block Janakpuri New Delhi


DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, Minstry of Ayush, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Jankpuri New delhi-110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S K Giri RO Ayu  Central Ayurveda Research Institute, Bangalore  Central Ayurveda Research Institute, Bangalore, #12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.) Kanakapura Main Road, Talaghattapura Post, Bengaluru – 560109 Phone No. 080-29535034 (0)/29635035 (H)
Bangalore
KARNATAKA 		 919483159755

giridr@yahoo.co.in 
Dr Sudhanshu Meher RO Ayu  Central Ayurveda Research Institute, Bhubaneshwar  Central Ayurveda Research Institute, Bhubaneshwar, Bharatpur, Near Kalinga Studio, Bhubaneswar-751029, Dist- Khorda, Odisha. Phone /Fax no: 0674-2387702 Email: nriadd.bhubaneswar@gmail.com
Khordha
ORISSA 		 9178009633

sudhanshumeher@gmail.com 
Dr Jetu rani Das RO Ayu  Central Ayurveda Research Institute, Guwahati  Central Ayurveda Research Institute, Guwahati, Borsojai, Beltola, Guwahati-781028 Phone No. 0361-2303714 E-mail: neiari.guwahati@gmail.com
Kamrup
ASSAM 		 9509192744

djeutirani@yahoo.in, 
Dr Sinimol RO Ayu  Central Ayurveda Research Institute, Kolkatta  Central Ayurveda Research Institute, Kolkatta, 4-CN Block, Sector – V, Bidhannagar, Kolkata – 700 091 Phone No. 033-2367-3881 E-mail: nriadd-kolkata@gov.in
Kolkata
WEST BENGAL 		 944651927

drsinitp@gmail.com  
Dr Govind Reddy AD Ayu  Central Ayurveda Research Institute, Mumbai   Central Ayurveda Research Institute, Mumbai, Raja Ramdeo Anandilal Podar (RRAP) Central Ayurveda Research Institute, RA Podar College, Worli, Mumbai-400018 Phone No. 022-24947259, 24947822
Mumbai
MAHARASHTRA 		 9820284671

acri-mumbai@gov.in  
Dr Saroj devi RO ayu  Central Ayurveda Research Institute, New Delhi   Central Ayurveda Research Institute, New Delhi , Road No.66, Punjabi Bagh, New Delhi – 110 026 Phone No. 011-25221059, 25229448
Central
DELHI 		 9882831485

dr.saroj965@gmail.com 
Dr Amit Gajarmal RO Ayu  Central Ayurveda Research Institute, Patiala   Central Ayurveda Research Institute, Patiala , Moti Bagh Road, Patiala-147001 Phone No. 0175-2223663, 2306529 E-mail: niapr-patiala@gov.in
Patiala
PUNJAB 		 9420162665

dgalaxy78@gmail.com 
Dr Pradeep Kumar RO Ayu  National Ayurveda Research Institute for Panchakarma, Cheruthuruthy  National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Via Shoranur, Thrissur Distt.Kerala, Phone no. 04884-262543-679531(Kerala)
Thrissur
KERALA 		 9048929886

nrip-cheruthuruthy@gov.in  
Dr Sojitra Niral RO ayu  Regional Ayurveda Research Institute, Ahemadabad  Regional Ayurveda Research Institute, Ahemadabad, Block A & D, 2nd Floor, Bahumali Bhavan, Manjushree Mill Compound, Near GirdharnagarOver Bridge, Asarwa, Ahmedabad-380004 Phone No. 079-29708072, 29708044 E-mail: rari.ahm@ccras.nic.in
Ahmadabad
GUJARAT 		 9574980226

sojitra.niral2@ccras.nic.in 
Dr Darasingh Rotwar RO ayu  Regional Ayurveda Research Institute, Gwalior   Regional Ayurveda Research Institute, Gwalior , Govt. Ayurvedic Hospital, Amkho, Gwalior-474009 Phone No.: 0751-2432698, 2323307 Email: nriashrd-gwalior@gov.in
Gwalior
MADHYA PRADESH 		 8827753466

dsrotwar7@gmail.com  
Dr Avinash Jain RO Ayu  Regional Ayurveda Research Institute, Jaipur  Regional Ayurveda Research Institute, Jaipur, Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016 Phone No. 0141-2281812, 2282618 E-mail: acri-jaipur@gov.in
Jaipur
RAJASTHAN 		 7425063398

vaidyaakjain@gmail.com 
Dr Sreekala Venugopal RO Ayu  Regional Ayurveda Research Institute, Lucknow  Regional Ayurveda Research Institute, Lucknow, Plot No. S-106, Sector -25,Near Sherwood Academy, Indira Nagar Lucknow- 226 016 Phone No. 0712-2714230 Email: nvari-lucknow@gov.in
Lucknow
UTTAR PRADESH 		 8547900265

sreev89@gmail.com 
Dr Sumedh Paikrao RO Ayu  Regional Ayurveda Research Institute, Nagpur  Regional Ayurveda Research Institute, Nagpur, Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur – 440009 (Maharashtra) Phone No. 0712-2714230 Email: ari.nagpur@gmail.com
Nagpur
MAHARASHTRA 		 7698825705

sampaikrao27@gmail.com  
Dr Ashok Sinha RO Ayu  Regional Ayurveda Research Institute, Patana  Regional Ayurveda Research Institute, Patana, Plot No. S-106, Sector -25, Near Sherwood Academy, Indira Nagar Lucknow- 226 016 Phone No. 0712-2714230 Email: nvari-lucknow@gov.in
Patna
BIHAR 		 7988581032

drashoksinha22@gmail.com  
Dr Sujata Dhoke RO Ayu  Regional Ayurveda Research Institute, Vijayawada  Regional Ayurveda Research Institute, Vijayawada, New Rajiv Nagar, Payakapuram, Vijayawada-520 015 (A.P.), India Phone No. 0866-2941757 E-mail: narivbd-vijayawada@gov.in
Krishna
ANDHRA PRADESH 		 7016289621

sujubasic@gmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Institutional Ethical committee of Central Ayurveda Research Institute Banglore   Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Bhuwaneshwar   Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Guwahati   Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Kolkatta  Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Mumbai  Submittted/Under Review 
Institutional Ethical committee of Central Ayurveda Research Institute New Delhi  Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Patiala  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Ahemadabad   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Cheruthuruthy  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Gwalior  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Jaipur  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Lucknow  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Nagpur  Submittted/Under Review 
Institutional Ethical Committee-Regional Ayurveda Research Institute Patana  Approved 
Institutional Ethical Committee-Regional Ayurveda Research InstituteVijaywada  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R198||Other specified symptoms and signsinvolving the digestive system and abdomen. Ayurveda Condition: AMLAPITTAJASULAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Drakshwaleha, Reference: AFI , Part-I, 3:15, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  99.00 Day(s)
Gender  Both 
Details  •Age more than 18 years.
•Chronic history of recurrent GI symptoms i.e. bloating, abdominal discomfort, dyspepsia and constipation of mild to moderate severity
•GSRS score more than equal to 3 for at least one question for above mentioned Symptoms
•Participants who are stable, ambulatory and willing to participate
 
 
ExclusionCriteria 
Details  • Known cases of defined underlying pathophysiology for GI disorders or known to have GI structural abnormalities
• Severe cases with gastrointestinal pathology e.g. IBD, colorectal cancer
• Uncontrolled or severe systemic illnesses
• Known case of diabetes mellitus
• History of use of laxatives or GI medications in the past 2 weeks
• Known allergy to any ingredient of Drakshavaleha
• Known cases of substance abuse, especially Opioids, including long-term medication
• Alcoholics or drug abusers
• Pregnant or lactating woman.
• Patients who have completed participation in any other clinical trial during the past six months.
• Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study.
• Any other condition that the PI considers to be unfavourable for participation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• Proportion of participants with remission of at least one symptom of FGIDs (assessed through GSRS) after treatment  • At the end of 1st, 2nd and 3rd month 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in Gastrointestinal Symptom Rating Scale (GSRS) scores after intervention   Baseline; at the end of 1st, 2nd and 3rd month 
2. Change in patient-reported well-being by WHO-5 Wellbeing Index   Time frame: Baseline and at the end of 3rd month 
3. Change in VAS score for appetite  felt in the past week 
4. Treatment adherence by the participants  Nil 
 
Target Sample Size   Total Sample Size="4500"
Sample Size from India="4500" 
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)   25/08/2025 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Functional Gastrointestinal Disorders (FGIDs) are defined as several variable combinations of chronic or recurrent gastrointestinal (GI) symptoms that do not have an identified underlying pathophysiology and that occur without any underlying structural abnormalities. FGID may include several separate idiopathic disorders that affect different parts of the gastrointestinal tract. FGIDs are the most common problem in gastroenterological practice.1

Although FGIDs are not life-threatening, they can substantially affect quality of life (QOL). FGIDs hold significant public health relevance as they are highly prevalent, can disrupt daily functioning, and contribute to considerable social and economic burdens. Consequently, their overall impact on population health is likely to be substantial.2 Functional GI symptoms such as chronic recurrent bloating, heartburn, dyspepsia and constipation are also common in the geriatric population due to age-related physiological changes, reduced mobility, dietary habits and due to various other medications.3,4 Gastrointestinal (GI) disorders significantly affect health-related quality of life (HRQOL), with a more pronounced impact observed in individuals suffering from functional GI disorders than those with organic GI diseases. The decline in HRQOL is closely linked to the severity of both psychological and gastrointestinal symptoms.5 Comorbid physical and mental illness can have a significant impact on the aetiology, presentation and treatment of gastrointestinal syndromes.6

Drakshavaleha, a classical Ayurvedic formulation with Draksha (Vitis vinifera) as the main ingredient, is known for its Vata-alleviating properties and mild laxative action. Traditional evidence suggests its use promotes smooth bowel movements and relieves abdominal discomfort. Moreover, studies have shown its effectiveness in managing constipation in pregnant women, which indicates its gentle and safe action on the gastrointestinal tract.7 Amalaki/Amla (Emblica Officinalis P) fruit juice is the base to mix all the ingredients in this medicine, and is a well-known Rasayana medicine (having nourishing properties, especially for age-related degeneration).8 Pippali (Piper longum) and other ingredients in Drakshavaleha further support digestive functions and Agni (digestive fire), which can be particularly beneficial in aged individuals with impaired digestion.9


This study aims to assess the effectiveness of the trial medicine, Drakshavaleha, in patients with functional gastrointestinal disorders (FGID), which is chronic and is prevalent in 35% new cases referred to a GE in clinic as per a published study (Shivaji UN and Ford AC. 2014.)10. Assuming that complete remission of all symptoms as per the score of the Gastrointestinal Symptom Rating Scale (GSRS) may be observed in at least 5% cases of FGID after administration of Drakshavaleha with a relative margin of 15% at a 95% confidence interval, the sample size is 3250. Adding a possibility of a 20% dropout, the total sample size becomes 3900, which may be rounded up to 4500 to distribute the sample size to 15 study sites. Each study site shall recruit at least 300 study participants
 
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