| CTRI Number |
CTRI/2026/03/105772 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of yatimadhu ksheer basti and yastimadhu churna in management of amlapitta w.s.r to hyperchlorhydria |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of yastimadhu Ksheer Basti and yastimadhu churna in management of amlapitta w.s.r to hyperchlorhydria |
| 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 Najnin Begum |
| Designation |
MD(Ayu) Scholar (Dept of Panchakarma) |
| Affiliation |
Department of panchakarma Government Ayurvedic College and Hospital Patna |
| Address |
Department of panchakarma Government Ayurvedic College and Hospital near Buddhamurti,Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
7273835115 |
| Fax |
|
| Email |
najninkumari52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Satyendra Kumar Tiwari |
| Designation |
HOD, Department of Panchakarma |
| Affiliation |
Department of panchakarma Government Ayurvedic College and Hospital Patna |
| Address |
Department of panchakarma Government Ayurvedic College and Hospital near Buddhamurti,Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
9024064735 |
| Fax |
|
| Email |
Satyendratiwari.25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Satyendra Kumar Tiwari |
| Designation |
HOD, Department of Panchakarma |
| Affiliation |
Department of panchakarma Government Ayurvedic College and Hospital Patna |
| Address |
Department of panchakarma Government Ayurvedic College and Hospital near Buddhamurti,Kadamkuan Patna
BIHAR
800003
India |
| Phone |
9024064735 |
| Fax |
|
| Email |
Satyendratiwari.25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital near Buddhamurti kadamkuan Patna Bihar 800003 |
|
|
Primary Sponsor
|
| Name |
Dr. Najnin Begum |
| Address |
Department of Panchakarma Government Ayurvedic College and Hospital near buddhamurti Kadamkuan,Patna Bihar 800003 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Najnin Begum |
Government Ayurvedic College and Hospital,patna |
OPD no.11,Panchkarma Department,near Budhha murti,Kadamkuan, Patna, Bihar
Patna
BIHAR |
7273835115
najninkumari52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kAla-bastiH, काल-बस्तिः | (Procedure Reference: yogratnakar, Procedure details: the basti prepared will be administered as for 16 days i.e anuvasana on day 1 then 6 anuvasana & 6 niruh basti alternatively for 12 days & final anuvasana on last 3 days of the trial.)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: yastimadhu churna, Reference: bhaavprakash nighantu,charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 16 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as Amlapitta according to Ayurvedic classical features like Avipaka, Klama, Utklesha,Tikta-Amla-udgara, Gourava, Hrit-kanda-daha and Aruchi will be randomly selected irrespective of sex, religion and occupation
Symptoms of hyperchlorhydria like heart and chest burn,throat burn,pungent-sour eructation,nausea,vomiting,indigestion,headache,fatigue etc
|
|
| ExclusionCriteria |
| Details |
• Lactating and pregnant women
• Patient suffering from other systemic illness which may interfere with course of treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
change in
time and symptoms of
amlapitta
avipaak
klama
utklesha
Tikta-amla udhgar
Guruta
Hrit-kantha daha
Aruchi |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
serological test for antibodies to H.pylori(if needed)
blood test for TLC,DLC,HB%,ESR.
LFT,KFT(if needed)
Endoscopy(if needed)
USG whole abdomen(if needed) |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="0"
Months="5"
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
|
This is a randomized, open, parallel group, interventional prospective trial comparing the efficacy of Yastimadhu Ksheer Basti and Yastimadhu Churna In management of Amlapitta with special reference to Hyperchlorhydria, that will be conducted in Government Ayurvedic College and Hospital at patna, Bihar in the Department of Panchkarma. In one group of 20 patients Yastimadhu ksheer basti will be done at early morning empty stomach for 16 days (alternate with anuvaasan basti with ksheerbala taila at afternoon after light diet) and in another group of 20 patients Yastimadhu chuma will be given 5gm/day orally at morning and evening empty stomach with water as anupaan for 30 days. The assessment will be done considering the subjective and objective parameters at pre-test i.e 0th day, mid-test assessment on 8th and 16th day respectively and post-test assessment on 30th day. |