Effect of Nagaradi decoction on digestive capacity

Phase 1/2

Not yet recruiting

• Conditions: Grahanidosha

• Registration Number: CTRI/2016/02/006670
• Lead Sponsor: IPGT RA GAU Jamnagar Gujarat

Brief Summary

This study is open label clinical study to evaluate the effect of Nagaradi Kashaya om Grahanidosha as well as on Agni and Doshavastha.

**PLAN OF STUDY**

The study will be carried out in two parts.

·         Conceptual study

·         Clinical study

**CONCEPTUAL STUDY**

**Materials and Methods:.**

All the available authentic classical texts of *Ayurveda,* viz. *Samhitas, Samgraha, Granthas* and their respective commentaries and texts written by eminent of scholars of modern era, latest journals, research papers, periodicals, articles, minutes of seminars, medical literature, available material on internet will be referred keenly to explore the subject. The compiled material will be critically analyzed and evaluated to form the conceptual base of study.

**CLINICAL STUDY**

**Materials and Method:**

A detailed and precised proforma will be designed to evaluate the effect of *Nagaradi Kashaya* on *Jatharagni* and on the state of *Doshas* in *Grahanidosha*. The drug selected for the study will be assessed clinically after taking the proper consent of patient.

**SELECTION CRITERIA:**

·         The patients having classical signs and symptoms of *Grahanidosha* viz. *Abaddha Mala-Pravritti* and *Sashleshma Mala-Pravritti, Sushka Varcha, Aam Varcha, Adhmana, Arochaka, Udargaurav, Parshvaruja*  etc. will be selected.

·         Patients will be selected from the age group of 16-40 years, irrespective of sex, religion and caste etc.

 **EXCLUSION CRITERIA:**

·         Age group of less than 16 years and more than 40 years

·         Worm infestation

·         Patients suffering from acute and chronic disease like Ulcerative colitis, Gastric and Peptic ulcer etc.

**INVESTIGATIONS:**

Following investigations will be carried out to rule out any other pathology:

1.      Complete blood count :

2.      Urine :

Routine and microscopic examinations.

3.      Stool :

Routine and microscopic examinations.

 **DRUGS AND GROUPING:**

**Study design:** Interventional

**No. of patients**: 30

**Name of drug :** *Nagaradi Kashaya (Ch.Chi. 15/98)*

**Ingredients:**

| | | | |

| --- | --- | --- | --- |

|**Dravya**

**Latin name**

**Part used**

**Proportion**

|*Nagara*

*Zingiber officinale* Roxb*.*

Rhizome

1 part

|*Musta*

*Cyperus rotundus* Linn*.*

Rhizome

1 part

|*Ativisha*

*Aconitum heterophyllum* Wall*.*

Root

1 part

**Form** : *Kashaya (decoction)*

**Dose :** 40 ml twice a day

***Sevankala :*** *Niranna Kala*

**Duration :** 2 weeks

**CRITERIA FOR ASSESSMENT:**

**Subjective:** Improvement in classical symptoms of *Grahanidosha*.

**Objective:** Change in investigations

Data generated during the above study will be presented in systemic manner and will be analyzed by paired t test. Collected, compiled and analyzed data will be presented with proper discussion and an attempt will be made to give concrete conclusion.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2016-02-20
• Study Start: 2016-02-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• The patients having classical signs and symptoms of Grahanidosha viz.
• Abaddha Mala-Pravritti and Sashleshma Mala-Pravritti, Sushka Varcha, Aam Varcha, Adhmana, Arochaka, Udargaurav, Parshvaruja etc.

Exclusion Criteria

Worm infestation Patients suffering from acute and chronic disease like Ulcerative colitis, Gastric and Peptic ulcer etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective: Improvement in classical symptoms of Grahanidosha, Agnibala and Doshavastha.	15 days
Objective: Change in investigations	15 days

Secondary Outcome Measures

Name	Time	Method
Subjective: Improvement in classical symptoms of Grahanidosha, Agnibala and Doshavastha.	Objective: Change in investigations

Trial Locations

Locations (1)

IPGT and RA Hospital; 🇮🇳 Jamnagar, GUJARAT, India

IPGT and RA Hospital

🇮🇳Jamnagar, GUJARAT, India

Zaibfatima Vakil

Principal investigator

9426314488

zaibvakil@gmail.com