Role of Jatyadi Ghrita Application, Rakta Prasadak Him and Draksha avleha in oral Cancer After Conventional Anti-Cancer therapy: A Single Arm Clinical Trial

ROLE OF JATYADI GHRITA APPLICATION, RAKTA PRASADAK HIM AND DRAKSHA AVLEHA IN ORAL CANCER AFTER CONVENTIONAL ANTI-CANCER THERAPY: A SINGLE ARM CLINICAL TRIAL

PLAN FOR DISSERTATION

Submitted to

DR. SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY JODHPUR (RAJASTHAN)

For the degree of

AYURVEDA VACHASPATI (M.D. Ay.- 2019-2022)

Post Graduate Department of Agad Tantra and Vyavahar Ayurveda

Under the Supervision & Guidance ofGUIDE****CO-GUIDE                                                               SCHOLAR

Dr. Sharad Porte

Dr. Kamal Kishor Lakhera

Dr. Rahish Ali Kureshi

|M.D. (Ay.)

M.Ch. (Surgical Oncologist)

M.D. (Ay.) Scholar

|Associate professor

N.I.A., Jaipur

Assistant professor

S.M.S. Medical college, Jaipur

P.G. 1st Year

N.I.A., Jaipur

P.G. Department of Agad Tantra and Vyavahar Ayurveda

National Institute of Ayurveda, Jaipur

App****lication for Dissertation

To

The Registrar,

Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur.

Through: - Proper Channel

Subject: - Requesting for Registration of the dissertation for the award of Ayurveda Vachaspati [M.D. (Ay.)] in Agad Tantra and Vyavaharayurveda in the session 2019-2022. Respected Sir,

With due respect, I would like to present following particulars and also enclose the revised synopsis of the dissertation with this application for your kind perusal and permission please.

Name of Scholar -

Dr. Rahish Ali Kureshi

|Father’s Name -

Abdul Mazeed Kureshi

|Date of Birth -

05/03/1986

|Permanent add. -

Ward no.6, Vyaparion ka mohalla, Muccam post dayara, Khandela

District. Sikar, Rajasthan. Pin: 332709

|Previous Exam Passed -

B.A.M.S. (2011), N.I.A. (National Institute of Ayurveda), Jaipur.

|Enrollment Number -

Applied for

|Name of Department -

P.G. Department of Agad Tantra

|Name of Institute -

National Institute of Ayurveda, Jaipur

Language of Dissertation -    English, Sanskrit, Hindi

Title of Dissertation -             ROLE OF JATYADI GHRITA APPLICATION, RAKTA PRASADAK

HIM AND DRAKSHA AVLEHA  IN ORAL CANCER AFTER CONVENTIONAL ANTI-CANCER THERAPY: A SINGLE ARM CLINICAL TRIAL

Under the Supervision & Guidance ofGUIDE****CO-GUIDE                                                               SCHOLAR

Dr. Sharad Porte

Dr. Kamal Kishor Lakhera

Dr. Rahish Ali Kureshi

|M.D. (Ay.)

M.Ch. (Surgical Oncologist)

M.D. (Ay.) Scholar

|Associate professor

N.I.A., Jaipur

Assistant professor

S.M.S. Medical college, Jaipur

P.G. 1st Year

N.I.A., Jaipur

P.G. Department of Agad Tantra and Vyavahar Ayurveda

National Institute of Ayurveda, Jaipur

ROLE OF JATYADI GHRITA APPLICATION, RAKTA PRASADAK HIM AND DRAKSHA AVLEHA IN ORAL CANCER AFTER CONVENTIONAL ANTI-CANCER THERAPY: A SINGLE ARM CLINICAL TRIAL

Introduction:

“Cancers are a large family of diseases that involve abnormal cell growth with the potential to invade or spread to other parts of the body.â€

On the basis of involvement of cells, the cancer are classified into Carcinoma, Sarcoma, Leukemia, Lymphoma and Myeloma. Cancer that begins in the skin or in tissues that line or cover internal organs are carcinoma, while the growth that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue are sarcoma. Leukemia are growth that starts in blood forming tissue, while lymphoma in cells of immune system. The cancer that begin in brain and spinal cord are gliomas, meningioma.

Global Statistics-2018 (WHO) shows that there are 18.1 million new cases all over world wide.

Indian Statistics-2018 shows 2.25 million people living with the disease, 1157294 are new cancer patients registered while 784821 are cancer related deaths.

Oral cancer, also known as mouth cancer, is cancer of the lining of the lips, mouth or upper throat. In the mouth, it most commonly starts as a painless white patch that thickens, develops red patches, an ulcer, and continues to grow. When on the lips, it commonly looks like a persistent crusting ulcer that does not heal, and slowly grows. Other symptoms may include difficult or painful swallowing, new lumps or bumps in the neck, a swelling in the mouth, or a feeling of numbness in the mouth or lips.

Risk factors include tobacco and alcohol use. With both tobacco and drinking alcohol, the risk of oral cancer is 15 times greater. Other risk factors include HPV infection, chewing Paan, and sun exposure on the lower lip. Diagnosis is made by biopsy of the concerning area, followed by investigation with CT scan, MRI, PET scan, and examination to determine if it has spread to distant parts of the body.

Oral cancer can be prevented by avoiding tobacco products, limiting alcohol use, sun protection on the lower lip, HPV vaccination, and avoidance of Paan. Treatments used for oral cancer can include a combination of surgery (to remove the tumor and regional lymph nodes), radiation therapy, chemotherapy, or targeted therapy. The types of treatments will depend on the size, locations, and spread of the cancer taken into consideration with the general health of the person.

In 2018, oral cancer occurred globally in about 355,000 people, and resulted in 177,000 deaths. Oral cancer has an overall 5 year survival rate of 65%. This varies from 84% if diagnosed when localized, compared to 66% if it has spread to the lymph nodes in the neck, and 39% if it has spread to distant parts of the body. Survival rates also are dependent on the location of the disease in the mouth.

Ayurveda is ancient medical science which has been giving the health solutions to the human race since ancient times. Though the term cancer is new for Ayurveda*.*

The basics principle for diagnosed and management the known or unknown diseases are well explained by using this basic principle of Ayurveda, the oral cancer can be diagnosed and treated.

Ayurveda is store of herbal, mineral and herbo-mineral medicines for various diseases including Arbuda. Though the Ayurveda has not mentioned oral cancer directly but the clinical features of oral cancer resembles as Mukhgata Dushta Vrana because of its ulcerative nature. The previous researches on herbal, mineral and herbo-mineral drugs for cancer are giving the enthusiasm in the field of role of Ayurveda therapy and drugs on cancer, as previous researches found significant. The anti-cancerous drugs like vincristine, vinblastine, paclitaxel etc. has also proven to be fruitful products scientifically and continuous drug research by medical scientist in field of development of anti-cancer drugs from natural drugs. But all these efforts are not enough as the problem is status quo and there is need to evaluate the new regimen for cancer which will be efficient and safe to the patient.

 Need of study:

As the world wide data suggest that cancer is the 2nd largest cause of death that occur due to any disease, while on the other hand the toxic effects of chemotherapy and radiotherapy are well known for hampering to patients. In advanced stage there is no cure, no solution of cancer in any pathy till date. Ayurveda is a store of basic principles and holistic medicines. By using these basic principles and holistic medicines there is a hope to improve the patient’s condition clinically. But there is need to evaluate and prove the efficacy of the Ayurveda therapy and drugs on cancer scientifically by using medical statistics.

 Rationale:

For this research work Jatyadi Ghrita and Rakta Prasadak Him will be used to treat this Mukhgat Dusta Vrana with special reference to ulcerative oral carcinoma wound.

Jatyadi Ghrita is mentioned in Sharangdhar Samhita Ghrita Kalpana Chapter 09/58-59. It is mentioned in the reference of Pidayukt Vrana, Dushta Vrana, Hard Varna etc. Jatyadi Ghrita contains Karanja, Chameli, Parwal, Haridra, Daruharidra, Madhuchchhishta, Madhuyasti, Kutki, Manjistha, Khas, Pipali, Tutha, Sariva and Nishotha. All the ingredient of Jatyadi Ghrita have Vrana Ropan and Shodhan properties.

Rakta Prasadak Him is a N.I.A. proprietary poly herbal drug. All the ingredients of Rakta Prasadak Him have Rakta Pitta Shamak properties, so that it will be used in this study for the Ropan of Mukhgat Dushta Vrana and for the Prasadan of Rakta. Rakta Prasadak Him contains Majistha, Usheer, Kakmachi , Bhumi amalki and Saariva. These drugs are used in cancer patient since six years in N.I.A.

Rakta Prasadak Him is a N.I.A. proprietary poly herbal drug which is being given in cancer Consultation & Treatment Unit of N.I.A., Jaipur for cancer patient hence it selected in clinical trial on a Study drug.

Draksha Avlehamainly contain Draksha and Amalaki which are best immuno-modulators. It also helps in curing chronic obstructive jaundice, liver disease, anemia, hyperacidity, indigestion. Hence it is included in this study as immuno-modulator which is need in cancer patient as well as to relieve the symptoms.

Hence the topic entitle ROLE OF JATYADI GHRITA APPLICATION, RAKTA PRASADAK HIM AND DRAKSHA AVLEHA IN ORAL CANCER AFTER CONVENTIONAL ANTI-CANCER THERAPY: A SINGLE ARM CLINICAL TRIAL**.**

 Hypothesis: Null hypothesis: There is no difference between the efficacy of Jatyadi Ghrita local application along with Rakta Prasadak Him and Draksha Avleha on symptom of oral cancer after and before treatment.

 Aims & Objectives: A) Aim:

·       To evaluate the effect of Jatyadi Ghrita and Rakta Prasadak Him on

ulcerative growth in oral cancer after conventional therapy.

B) Objectives:

·       To evalute the improvement in quality of life in patient of oral cancer.

·       To evaluate the effect of Ayurvedic medicine on conventional therapy induced oral mucositis.

 Material & Method: Study type: A single arm clinical trial.

Phase of trail: 2nd

Target sample size: 10 patients

Site/s of study: N.I.A. Hospital, Jaipur and S.M.S. Hospital, Jaipur.

Method of generating randomization sequence: computer generated.

Date of first enrolment: After the approval from ethical committee and CTRI registration.

Estimated duration of trail: 30 days.

 Clinical study:·       10 Known diagnosed Patients of Oral cancer will be selected from I.P.D. or O.P.D. Cancer Consultation & Treatment Unit N.I.A., Jaipur and S.M.S. hospital, Jaipur.

·       Selection of patients will be mainly based on the Biopsy or FNAC report.

·       A special research proforma will be prepared for studying the patients as well as the disease.

Clinical Group of Study:10 Selected patients of Oral cancer.

 Study Group:10 patients of known case of oral cancer following conventional anti-cancer therapy     (including either Surgery, Radiotherapy or Chemotherapy),   will be given Jatyadi Ghrita and Rakta Prasadak Him along with *Drakshavleha.*Inclusion CriteriaØ  The patients between the age group of 30 to 70 years diagnosed with oral carcinoma.

Ø  Patient willing to sign the consent forms.

 Exclusion Criteria

Ø  Patients suffering from major systemic illness like diabetes, liver cirrhosis, MI, IHD,

Sr.

No.

Clinical Features

Study Group

|Before Study

After Study

|1

Red, white or mixed red-white lesions

|2

Ulcer lasting longer than three weeks

|3

Pain, especially associated with the tongue

|4

Swelling inside mouth or in neck area

|5

Discomfort with speech and swallowing

Hypertension and renal failure.

Assessment of patients shows the clinical improvement in associated signs and symptoms of oral cancer following conventional anti-cancer therapy-

        Assessment of patients shows the clinical improvement in associated signs and symptoms of Oral Mucositis following conventional anti-cancer therapy- 

Sr.

No.

Clinical Features

Study Group

|Before Study

After Study

|1

Oral pain

|2

Burning

|3

Erythema

|4

Ulcerations

|5

Difficulty with mouth care regimens

|6

Difficult eating, drinking and speaking

            Gradation of signs and symptoms

None

Mild

Moderate

Severe

|0

1

2

3

Mucositis grading according to the World Health Organization

0- Mucous membrane without change

1- Mucous membrane has mild inflammation and sometimes mild pain that does not need anti-inflammation medication

2- Point mucositis associated with mild serous, inflammatory discharge and mild pain that needs pain killer

3- Diffused and continuous mucositis with fibrous discharges and severe pain that needs pain killer

Assessment of QOL (quality of life) in Oral cancer:

Sr.no

QQL

Befor treatment

After Treatment

|1

Physical Well being

|2

Psychological well being

|3

Social Well being

|4

Spiritual Well being

 

Assessment and Grading

Never

=1

Seldom

= 2

Some Time

=3

As often as not

=4

Frequently

= 5

Very often

=6

Always

=7

STUDY GROUP

JATYADI GHRITA***:*** SHARANGDHAR SAMHITA**:(Chapter 09/58-59****)**

Sr. No.

Content

Botanical name

Part used

Part

|1

Karanj

Millenttia Pinnata Linn.

New leaf and Kachhe Phal

1part

|2

Chameli

Jasminum officinale Linn.

Leaf

1part

|3

Patol

Trichosanthes Dioica. Roxb.

Leaf

1part

|4

Neem

Azadirachta Indica A. juss

Leaf

1part

|5

Haridra

Curcuma longa Linn.

Kand

1part

|6

Daruhldi

Berberis Aristata DC

Kand

1part

|7

Yastimadhu

Glycyrrhiza Glabra Linn.

Root

1part

|8

Kutki

Picrorhiza Kurrooa Royle

Root

1part

|9

Sikta (Mom)

 1part

|10

Sariva

Hemidesmus indicus Linn.

Root

1part

|11

Neela thotha (Tutth)

 1 part

|12

Manjista

Rubia Cardifolia Linn.

Root

1 part

|13

Chandana

Santalum album Linn.

Kandsar

1 part

|14

Nishoth

Operculina turpethum Linn.

Mooltwak

1 part

|15

Utpal

Nelumbo nucifera Gaertn

Panchang

1 part

|16

Sarpi

Ghrita

|17

Khas

Chrysopogon Zizanioides Linn.

Seed

1 part

Preparation method- Jatyadi Ghrita will be prepared by taking one part Kalk of the each constituent in equal quantity. Then the drug will be prepared by the standard method of Ghritapak.

Route of administration:-.Application of Ghrita on Ulcerative Growth

Dose:- twice a day

Duration:- 30 days

       RAKTA PRASADAK HIM:(N.I.A. proprietary poly herbal drug)

 

Sr. No.

Content

Botanical name

Part used

Part

|1.

Majistha

Rubia cardifolia Linn.

Twak

1part

|2.

Sariva

Hemidesmus indicus Linn.

Root

1part

|3.

Usheer

Vetiveria zizanioidis Linn.

Kand

1part

|4.

Kakmachi

Solanum nigrum Linn.

Twak and Pushpa

1part

|5

Bhumi Amlaki

Phyllanthus urinaria Linn.

Panchang

1 Part

Preparation:- Rakta prasadak Him  will be prepared by taking one part of the all constituents in equal quantity. Coarse powder of these drugs will be soaked in 6 times of water for 6 to 12 hours. It will be prepared according to preparation method as described in Shastra for Him Kalpna.

Route of administration:- through oral route

Dose:- 40 ml. twice a day

Duration:- 30 days

Diet :- The diet will be modified as per Ayurveda science in both groups. DRAKASHA AVLEHA:

Sr. No.

Content

Botanical name

Part used

Part

|1

Draksha

Vitis vinifera Linn.

Fruit

768 g

|2

Pippali

Piper longum Linn.

Fruit

768 g

|3

Sharkara

Sugar

2.800 kg

|4

Yashtimadhu

Glycyrrhiza glabra Linn.

Root

96 g

|5

Shunthi

Zingiber officinale Roscoe

Rhizome

96 g

|6

Tvakshiri

Bambusa arundinacea willd

96 g

|7

Dhatri

Embelica officinalis Gaertn

Phalarasa

12.288 l

|8

Madhu

Honey

-

768 g

Dose- 6 gm. twice a day with milk after meals

Duration- 30 days

 Observation and Result:A detail proforma will be created to carry out this study in a scientific way. All demographic data related to patient along with sign and symptom of disease will be noted on 1st day, 15th day and 30th day of study. The clinical efficacy of study drugs will be assessed on the basis of sign and symptom and their difference before and after treatment. The result will be presented in the form of table, graph and diagram. Data obtained during the study will be analyzed statistically by using appropriate test of significance suitable for the study.

Summary and Conclusion:The finding as observation and result will be summarized and conclusion will be carried out on the basis of observation and result.

 PROPOSED CONTENTS OF THE DISSERTATION Present research work will be presented in the form of a thesis, which will include following Contents:

1.       Benediction

2.       Acknowledgement

3.       Introduction

4.       Review of literature

(i)                           Ayurveda Aspects of Oral Cancer and associated signs and symptoms.

(ii)                        Modern review of oral cancer.

5. Drug Review- RAKTA PRASADAK HIM, JATYADI GHRITA, DARKSHAVLEHA.

6.       Comparative clinical trial

(i)                           Material &Methods

(ii)                        Observation & Result

7.       Discussion

8.       Summary &Conclusion

9.       Reference &Bibliography

10.   Appendix

GUIDE****CO-GUIDE                                                               SCHOLAR

Dr. Sharad Porte

Dr. Kamal Kishor Lakhera

Dr. Rahish Ali Kureshi

|M.D. (Ay.)

M.Ch. (Surgical Oncologist)

M.D. (Ay.) Scholar

|Associate professor

N.I.A., Jaipur

Assistant professor

S.M.S. Medical college, Jaipur

P.G. 1st Year

N.I.A., Jaipur

P.G. Department of Agad Tantra and Vyavahar Ayurveda

National Institute of Ayurveda, Jaipur

ROLE OF JATYADI GHRITA APPLICATION, RAKTA PRASADAK HIM AND DRAKSHA AVLEHA IN ORAL CANCER AFTER CONVENTIONAL ANTI-CANCER THERAPY: A SINGLE ARM CLINICAL TRIAL

Presentation of synopsis in the form of Panchavayava Vakya

Submitted to

DR. SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY JODHPUR (RAJASTHAN)

For the degree of

AYURVEDA VACHASPATI (M.D. Ay.- 2019-2022)

Post Graduate Department of Agad Tantra and Vyavahar Ayurveda

    Under the Supervision & Guidance of GUIDE****CO-GUIDE                                                               SCHOLAR

Dr. Sharad Porte

Dr. Kamal Kishor Lakhera

Dr. Rahish Ali Kureshi

|M.D. (Ay.)

M.Ch. (Surgical Oncologist)

M.D. (Ay.) Scholar

|Associate professor

N.I.A., Jaipur

Assistant professor

S.M.S. Medical college, Jaipur

P.G. 1st Year

N.I.A., Jaipur

P.G. Department of Agad Tantra and Vyavahar Ayurveda

National Institute of Ayurveda, Jaipur