Comparative Clinical Study To Evaluate The Efficacy Of Chaturbhadra Kwath With Panchamrita Parpati Vati In The Management Of Grahani.

Phase 3

Not yet recruiting

• Conditions: Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH,

• Registration Number: CTRI/2023/06/053939
• Lead Sponsor: Dr Aishwarya Karandikar

Brief Summary

TITLE OF DISSERTATION -  RANDOMIZED CONTROLLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHATURBHADRA KWATH WITH PANCHAMRITA PARPATI VATI IN THE MANAGEMENT OF GRAHANI

AIM AND OBJECTIVES: Aim: To Evaluate The Efficacy of Chaturbhadra Kwath with Panchamrita Parpati Vati In The Management Of Grahani.

Objectives: 1] To evaluate the efficacy of Chaturbhadra Kwath in the management of Grahani.

2] To evaluate the efficacy of Panchamrita Parpati Vati in the management of Grahani.

3]To compare the efficacy of Chaturbhadra Kwath with Panchamrita Parpati Vati in the Management of Grahani.



RESEARCH QUESTION-

Primary Research Question: - Is Chaturbhadra Kwath effective in the management of Grahani?

Secondary Research Question: - Is the effect of Chaturbhadra Kwath significant than Panchamrita Parpati Vati in the management of Grahani?



HYPOTHESIS:

H0: There will be no significant effect of Chaturbhadra Kwath than Panchamrita Parpati Vati in management of Grahani.

H1: There will be significant effect of Chaturbhadra Kwath than Panchamrita Parpati Vati in management of Grahani.



DIAGNOSTIC CRITERIA:- • The parameters for diagnosis are completely based on classical signs and symptoms like Muhur Baddha and Muhur Drava Mala Pravritti, Aruchi, Udarshoola, Prasek, Udgara Pravrutti, Trishna, Arochak,Videha, Pada Shoth, Aalasya, Tama Pravesh, Bala Kshay and Chardi. • Assessment of Agni • Blood investigation (CBC, LFT, Sr.Creatinine, BSL- F, PP) • Stool Examination Routine and Microscopic • Urine examination Routine and Microscopic



MATERIALS Group A (ChaturbhadraKwath)- Shunthi, Guduchi, Ativisha, Musta



SOP OF PREPARATION OF CHATURBHADRA KWATH:- Raw material for Chaturbhadra Kwath will be purchased from authentic pharmaceutical company. The raw materials will be identified and authorized by Department of Dravya Guna, D.Y.Patil Deemed to be University, School of Ayurveda. According to the procedure mentioned in Sharangdhar Samhita, One pala of each coarsely powdered drugs will be boiled with 16 parts of water over mild flame till the liquid is reduced to 1/8th of the original quantity. The Chaturbhadra Kwath will be formed in the terms of Syrup through authentic GMP certified company.



DOSE: Chaturbhadra Kwath 40 ml BD



GROUP B (Panchamrita Parpati Vati): - Shuddha Parad, Shuddha Gandhak, Abhrak Bhasma, Loha Bhasma, Tamra Bhasma



SOP OF PREPARATION OF PANCHAMRITA PARPATI VATI:- Panchamrita Parpati will be prepared at Rasashala, a G.M.P certified pharmaceutical company from Pune. The reference used for this preparation is from Rasendra Sara Sangraha. Firstly, Kajjali will be prepared by rubbing mercury with sulphur in a khalva (mortar).Other ingredients will be incorporated,blended thoroughly and heated over mild flame. The molten liquid will be pressed between the Kadali leaves one with cow-dung bolus and other spreaded over cow dung platform. These thin flakes will be collected, made into fine powder and then tablets will be formed.Tablet will be made by tablet punching machine.



DOSE: Panchamrita Parpati Vati 250 mg BD (125 mg each tablet) with Koshna Jala



ASSESSMENT CRITERIA-

All the signs ans symptoms of Grahani as mentioned by Acharya Charak will be assessed before and after treatment.

Symptoms are-

1.MuhurBaddha / Muhur Drava Mala Pravritti

2.Mala Swaroop

3. Udgara Pravritti

4. Trishna

5. Arochaka

6. Vidaha

7. Pada Shoth

8. Aalasya

9.Tama Pravesha

10. Prasek

11. Bala Kshaya

12. Chardi

 

STATISTICAL ANALYSIS: Efficacy of Subjective criteria will be analysed by Wilcoxon signed rank test, Efficacy of Objective criteria will be analysed by student paired t-test, Subjective parameters in between group will be compared by Mann Whitney U Test, Objective parameters in between the groups will be compared by Unpaired t-test.



DISCUSSION AND CONCLUSION: Discussion, Conclusion & Summary will be prepared based on result found

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-14
• Study Start: 2023-06-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinically diagnosed patients fulfilling the subjective criteria of Grahanidosha.
• Muhur Baddha, Muhur Drava Mala Pravritti, Aruchi, Udarshool, Prasek, Udgara Pravritti, Trishna, Arochak, Vidaha, Pada Shoth, Aalasya, Tama Pravesh, Balakshaya, Chardi.

Exclusion Criteria

Patients suffering from acute diarrhoea, intestinal tuberculosis, ulcerative colitis, gastric and peptic ulcer, strictures, colonic cancer, toxic mega colon, pregnancy, haemorrhage , perforation, immune-compromised, uncontrolled diabetes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief from the subjective assessment criteria i.e clinical signs and symptoms of Grahani like Muhur Baddha/Muhur Drava Mala pravritti, Mala Swaroop, Udgara Pravritti, Trishna, Arochaka, Vidaha, Pada Shoth, Aalasya,Tama Pravesh, Prasek, Bala Kshay and Chardi.	The outcome will be assessed at baseline, 15th day and 30th day

Trial Locations

Locations (1)

DY Patil School of Ayurveda; 🇮🇳 Thane, MAHARASHTRA, India

DY Patil School of Ayurveda

🇮🇳Thane, MAHARASHTRA, India

Dr Aishwarya Karandikar

Principal investigator

9260186212

karandikaraishwarya@gmail.com