| CTRI Number |
CTRI/2025/12/099616 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Indigestion with the Unani Medicine Jawarish-e-Javed. |
|
Scientific Title of Study
|
Clinical Validation Study of Unani Pharmacopeial Formulation Jawarish-e-Javed in Zof-e Meda (Functional dyspepsia) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZM/FD/JJ/CLNVAL/CCRUM/23-24, Version- 01, 27-08-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Younis I Munshi |
| Designation |
Deputy Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
South West
DELHI
110058
India |
| Phone |
09419086700 |
| Fax |
|
| Email |
younismunshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support:Regional Research Institute of Unani
Medicine, Chennai |
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
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 Mustaqueem Khan |
Regional Research Institute of Unani Medicine |
Research OPD Room Zof-e Meda (Functional dyspepsia), 1, West Meda Church Street, Royapuram, Chennai–600013
Chennai
TAMIL NADU |
7620093225
mustaqueemk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jawarish-e- Javed |
5 gm BD taken orally with water after meal for 6 weeks. |
| Comparator Agent |
Nill
|
Nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients of either sex in the age group of 18-65 years.
2-Patients meeting the Rome IV Criteria (Postprandial Distress Syndrome) as under
3-Patients with Mild to moderate dyspepsia as defined by a score ranging between 1-15 as per the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) |
|
| ExclusionCriteria |
| Details |
1- Patients with Severe dyspepsia as defined by a score ranging more then 15 as per the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ).
2- Patients showing alarm symptoms (weight loss, anemia, hematemesis, melena, dysphagia, palpable abdominal mass).
3- Patients with systemic illness e.g.Diabetes/Hypertension/Tuberculosis/Anemia.
4- Known case of Gastric peptic ulcer with H. pylori Infection or reflux esophagitis within the past 6 months were excluded
5- Known case of gastrointestinal surgery.
6- Known cases of Intra-abdominal malignancy (e.g. stomach/Pancreas/Liver or Gastricleiomyoma/Leiomyosarcoma/Malignant Lymphoma)
7- Patient requiring long term therapy e.g. Hepatic, Renal or Cardiac Ailments.
8- History of surgery related with the gastrointestinal tract more than six months
9- Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the signs and symptoms of Zof-e Meda (Functional dyspepsia). Which will be assessed on the basis of Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ). |
At baseline and every two weeks during the treatment period (i.e., at 0, 2nd, 4th, and 6th week). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical investigations for safety assessment i.e.,Haemogram, LFT, KFT, stool and Urine R/M. |
At baseline and at the end of treatment.( i.e., 0 and 6th week) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
30/12/2025 |
| 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="2"
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
|
This study is designed as a single centric open trial in patients with Zof-e Meda (Functional dyspepsia) . After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria. The patients will be assessed clinically at baseline and every two weeks of the treatment. (i.e., 0, 2th, 4th and 6th week) . This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 06 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy (i.e., 0, and 6th week).
Composition of Jawarish-e- Javed: | S. No. | Ingredients | Botanical / Scientific Name | Part used | Quantity | | 1. | Jauzbuwa | Myristica fragrans Houtt. | Fruit kernel | 25 gm | | 2. | Bisbasa | Myristica fragrans Houtt. | Aril | 25 gm | | 3. | Qaranful | Syzygium aromaticum Linn. | Flower bud | 25 gm | | 4. | Darchini | Cinnamomum verum J.Presl | Stem bark | 25 gm | | 5. | Sumbul-ut-teeb | Nardostachys jatamansi (D. Don) DC | Rhizome | 25 gm | | 6. | Sad Kufi | Cyperus rotundus Linn | Rhizome | 25 gm | | 7. | Amla Munaqqa | Phyllanthus emblica L | Deseeded fruit | 25 gm | | 8. | Dana Heel Khurd | Elettaria cardamomum (L.) Maton | seed | 25 gm | | 9. | Qand Safaid | Sugar | As such | 400 gm | |