| CTRI Number |
CTRI/2023/05/052901 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Indigestion with Unani medicine Habb e Pachlona |
|
Scientific Title of Study
|
Clinical validation of Unani pharmacopoeial formulation Habb-e-Pachlona in Su al-Hadm (Dyspepsia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SH FD/HP/CLNVAL/CCRUM/20-21, version 01,18/11/22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| 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
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| 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
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.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
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Aligarh, Clinical Research Unit, Burhanpur; Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine (CCRUM), New Delhi |
| 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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yasmin Fatima |
Clinical Research Unit |
Research OPD Room Sue Hazm (Dyspepsia), Saeeda Hospital Campus Ganpati Naka
West Nimar
MADHYA PRADESH |
8827166845
yasfatima2014@gmail.com |
| Dr M Naseem |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD Room Sue Hazm (Dyspepsia), Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH |
8451934661
naseemrrium786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Unit (CRU), Burhanpur |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Aligarh |
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 |
Habb-e-Pachlona |
500g-1g twice daily orally after meals with water for 2 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 18-60
2. Patients meeting the Rome III diagnostic criteria for PDS
|
|
| ExclusionCriteria |
| Details |
1. Presence of GI ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa or suspicious malignant lesion based on clinical diagnosis.
2. Having overlap syndrome combined with gastro esophageal reflux disease or irritable bowel syndrome
3. Having alarm symptoms (weight loss, black or tar stool, dysphasia, etc.)
4. Having any systemic disease (diseases of heart, lung, liver or kidney) or mental illness
5. History of surgery related with the gastrointestinal tract more than six months ago
6. Taking drugs which may affect the gastro intestinal tract, such as non-steroidal anti-inflammatory drugs and aspirin
7. Known Allergy to the experimental medications
8. Pregnant and breastfeeding
9. Refusing to sign the informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy will be assessed on the basis of assessment of patients clinically i.e. improvement in sign and symptoms |
At baseline and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline and 14th day |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
30/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
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 multicentric open trial in patients with Sue Hazm (Dyspepsia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Habb e Pachlona 500mg-1g twice daily orally with water after meals for 2 weeks. The patients will be assessed at baseline and 14th day. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Habb-e-Pachlona
| S. No. | Ingredients | Botanical / Scientific Name | Quantity | | 1 | Nankhwah | Ptychotisajowan DC. | 250 g. | | 2 | Badiyan | Foeniculum vulgare Mill. | 250 g. | | 3 | Kishneez Khushk | Coriandrumsativum Linn. | 125 g. | | 4 | Zeera Safaid | Cuminumcyminum | 40 g. | | 5 | Zeera Siyah | Cuminumcarvi Linn. | 40 g. | | 6 | Waj-e-Turki | Acoruscalamus Linn. | 40 g. | | 7 | Zanjabeel | ZingiberofficinaleRosc. | 40 g. | | 8 | Filfil Daraz | Piper longum Linn. | 40 g. | | 9 | Filfil Siyah | Piper nigrum Linn. | 40 g. | | 10 | Aamla | Emblica officinalis Gaertn. | 40 g. | | 11 | Post Balela | Terminalia bellericaRoxb. | 40 g. | | 12 | Post Halela Zard | Terminalia chebula Retz. | 40 g. | | 13 | Zaranbad | Curcuma zedoriaRosc. | 25 g. | | 14 | Pudina | Menthaarvensis | 25 g. | | 15 | Namak Sang | Massicot, Litharge (Monoxide of Lead) | 10 g. | | 16 | Namak Siyah | | 10 g. | | 17 | Namak Sanbhar | Lake Salt | 10 g. | | 18 | Aab-e-Lemu Kaghzi | Citrus aurantifolia | Q. S. | | 19 | Aab-e-AamlaTaza | Emblicaofficinale | Q. S. | |