Treatment of Indigestion with Unani medicine Habb e Pachlona

Phase 3

Not yet recruiting

Conditions: Functional dyspepsia,

Registration Number: CTRI/2023/05/052901

Lead Sponsor: Central Council for Research in Unani Medicine (CCRUM), New Delhi

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

*Zingiberofficinale*Rosc.

**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 bellerica*Roxb.

**40 g.**

|12

Post Halela Zard

*Terminalia chebula* Retz.

**40 g.**

|13

Zaranbad

*Curcuma zedoria*Rosc.

**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.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

Patients of either sex in the age group of 18-60 2.
Patients meeting the Rome III diagnostic criteria for PDS.

Exclusion Criteria

Presence of GI ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa or suspicious malignant lesion based on clinical diagnosis.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	At baseline and 14th day

Trial Locations

Locations (2): Clinical Research Unit
🇮🇳
Nimar, MADHYA PRADESH, India
Regional Research Institute of Unani Medicine (RRIUM)
🇮🇳
Aligarh, UTTAR PRADESH, India
Clinical Research Unit
🇮🇳Nimar, MADHYA PRADESH, India
Dr Yasmin Fatima
Principal investigator
8827166845
yasfatima2014@gmail.com