| CTRI Number |
CTRI/2024/11/077102 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Draksha Abhaya churna in the management of Amlapitta. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the efficacy of Draksha Abhaya churna in the management of Amlapitta. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Sushil Arjunrao Kale |
| Designation |
Pg Scholar |
| Affiliation |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa ,Bhartiya sanskriti Darshan Trusts Ayurved Mahavidyalaya,Vishwashanti Dham Kesanand Road, Wagholi,Pune-412207 Maharashtra
Pune
MAHARASHTRA
412207
India
Pune
MAHARASHTRA
412207
India |
| Phone |
8657349991 |
| Fax |
|
| Email |
sushil827567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Anjali Aniruddha Deshpande |
| Designation |
Professor and HOD of Kayachikitsa |
| Affiliation |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya wagholi pune maharashtra 412207 |
| Address |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti Dham Kesanand road Wagholi Pune-412207 Maharashtra India
Pune
MAHARASHTRA
412207
India
Pune
MAHARASHTRA
412207
India |
| Phone |
9730069747 |
| Fax |
|
| Email |
anjalidesh1610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Anjali Aniruddha Deshpande |
| Designation |
Professor and HOD of Kayachikitsa |
| Affiliation |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya wagholi pune maharashtra 412207 |
| Address |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti Dham Kesanand road Wagholi Pune-412207 Maharashtra India
Pune
MAHARASHTRA
412207
India
Pune
MAHARASHTRA
412207
India |
| Phone |
9730069747 |
| Fax |
|
| Email |
anjalidesh1610@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishawashanti dham kesanand road Wagholi Pune 412207 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya |
| Address |
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti dham Kesanand road Wagholi Pune 412207 Maharashtra India |
| Type of Sponsor |
Private medical college |
|
|
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 Sushil Arjunrao Kale |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
Department of Kayachikitsa OPD and IPD of Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti dham Kesanand road Wagholi Pune Maharashtra 412207 India
Pune
MAHARASHTRA |
8657349991
sushil827567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Draksha Abhaya churna , Reference: Kaviraj Shri. Ambikadatt Shastri Ayurvedacharya, Shri Govindadasvirachit, BhaishajyRatnavali, ChaukhambaPrakashan,Edition 18th, Athamlpittprakaranam 56, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avipattikar churna , Reference: Kaviraj Shri. Ambikadatt Shastri Ayurvedacharya, Shri Govindadasvirachit, BhaishajyRatnavali, ChaukhambaPrakashan,Edition 18th, Athamlpittprakaranam 56, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshnajala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having symptoms Tikta-amlodgar, Chardi, Aruchi, Hrudkanthadaha, Gaurava, Klama, Avipak, Utklesha, Kandu, Shiroshoola. 2. Patients having at least 3-4 above mentioned symptoms.
3. Patients between age group 20 to 60 years of any gender. |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from uncontrolled Diabetes mellitus, Hypertension and Thyroid disorders with complications.
2. Patient with known case of gastric ulcer, duodenal ulcer, stomach cancer.
3. Long-term addictions like alcoholism, smoking, tobacco chewing etc.
4. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and document the efficacy of Draksha Abhaya churna in the management of Amlapitta . |
assessment on 0th 7th 14th 21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out adverse effect of Draksha Abhaya if any |
assessment on 0th 7th 14th 21th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study is randomised controlled clinical trial to study the efficacy of Draksha Abhaya churna in the management of Amlapitta. The diagnosed patient of Amlapitta will be divided in two equal group Experimental and Control group. The treatment for experimental group is Draksha Abhaya churna 3gm with Honey twice a day for 14 days and Avipattikar churna 3gm with warm water for 14 days for control group will be given and assesment will be done on 0th , 7th , 14th and 21st day. In the 21st century, more attraction for fast food, copying the western life style, change in diet habits and behavioral pattern, stress and strain hampers the process of digestion and leads to gastritis, hyperacidity, non-ulcer dyspepsia, ulcerative dyspepsia. Among which non-ulcer dyspepsia is most common. The prevalence rate of non-ulcer dyspepsia in India range is 30.4%.Modern treatment for hyperacidity, non-ulcer dyspepsia is Antacid, H2 Blocker, and Proton Pump Inhibitors and are liable to have many side effects. Symptoms like nausea, heart burn, acid reflux, loss of appetite, indigestion included in non-ulcer dyspepsia, which resembles to symptoms of Amlapitta in Ayurveda. Ayurved recommends shaman (Internal treatment) and shodhan chikitsa (detoxification treatment) for the treatment of Amlapitta.The Draksha Abhaya churna mentioned in ayurvedic text (Bhaishajyratnavali) is Madhura Vipaka and act as Deepan, Pachana, Hrudya, Vatanulomak, Rasayan, Swarya, Agnidipan properties reliving Amlapitta selected for the current study which is easily available and cost effective. |