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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 16  |  Issue : 2  |  Page : 92-98

An open-label randomized comparative clinical study of Triphaladi vati and Jatyadi gandusha on Tobacco Chewing-Induced Mukhapaka w.s.r. to stomatitis


1 Department of Agad Tantra Evam Vyavahara Ayurved, Punjab Ayurved Medical College and Hospital, Sriganganagar, Rajasthan, India
2 Department of Agad Tantra Evam Vyavahara Ayurved, Shekhawati Ayurved Medical College, Pilani, Rajasthan, India

Date of Submission25-Nov-2021
Date of Decision14-Jan-2022
Date of Acceptance17-Jan-2022
Date of Web Publication4-Jul-2022

Correspondence Address:
Sunita Kumari Bijarniya
Department of Agad Tantra Evam Vyavahara Ayurved, Punjab Ayurved Medical College and Hospital, Morjand Khari, Sriganganagar - 335 037, Rajasthan
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/joa.joa_347_21

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  Abstract 


Introduction: According to Ayurveda, tobacco plant (Sthavara Patra Visha) has properties such as Tikta and Katu rasa, Laghu, Tikshna, Vyavayi, Sara, Vikashi, and Ushna guna; all the properties match with Dushi visha (slow poison) induces chronic toxicity to the gastrointestinal tract on chronic use. Tobacco chewing causes Mukhapaka (Sarvasara roga) which is the clinical condition identified with Paka, Lalima (redness), Daha (burning sensation), Sphota (mouth ulcers/blisters), Ksharokshit kshatsam (erosion of buccal mucosa), Vedna (pain), Tikta vaktrata (bitter taste), difficulty in chewing, and enlargement of lymph nodes. Mukhapaka is a Pitta Pradhana Sansargaja vyadhi. Gandusha and Virechaka drugs are found effective to treat Mukhapaka. Triphaladi vati and Jatyadi gandusha are defined as Mukha roga treatment as the both Yogas have Rasayana (immunity booster), Deepana (appetizer), Vishaghna (detoxifier), Vranaropana (wound healing), Pittasamsrana (anti-inflammatory), and Sandhanakara (healing) properties useful in Mukhapaka (stomatitis). This study aims to access and compare the efficacy of Triphaladi vati and Jatyadi gandusha in Mukhapaka treatment. Methods: (i) Design: Open-labeled randomized comparative clinical trial of 30 patients of either sex. (ii) Intervention: 30 clinically diagnosed and Rajasthan Ayurved University (Jodhpur) outpatient department-registered patients of Mukhapaka (stomatitis) who were randomly divided into two groups (Group A and Group B) of 15 patients each. (iii) Duration: 45 days. Results: Both the selected preparations were found very effective in the treatment of Mukhapaka, but the most efficacy was seen in Group B which was given Jatyadi gandusha. Conclusion: The present study supports the use of both Yogas in treating Mukhapaka with the good acceptance by all treated patients.

Keywords: Jatyadi gandusha, Mukhapaka, tobacco chewing, Triphaladi vati


How to cite this article:
Bijarniya SK, Jangid SK. An open-label randomized comparative clinical study of Triphaladi vati and Jatyadi gandusha on Tobacco Chewing-Induced Mukhapaka w.s.r. to stomatitis. J Ayurveda 2022;16:92-8

How to cite this URL:
Bijarniya SK, Jangid SK. An open-label randomized comparative clinical study of Triphaladi vati and Jatyadi gandusha on Tobacco Chewing-Induced Mukhapaka w.s.r. to stomatitis. J Ayurveda [serial online] 2022 [cited 2022 Aug 10];16:92-8. Available from: http://www.journayu.in/text.asp?2022/16/2/92/349770




  Introduction Top


At present, chewing tobacco products is a major health problem. India's tobacco production is third after China and the U.S.[1] Tobacco possesses thousands of chemical harmful compounds. They act not only as irritants and toxins but also are deadly carcinogens. Nicotine, the chief alkaloid present in tobacco, is mainly responsible for addiction. Here, the study is about smokeless tobacco (SLT) use. Mukhaguha is covered with Mridu (soft), Vahini Pradhana (vascular), Shaleshama Pradhana Shleshmakala (slimy cough coating), which secretes Tanu Shleshma (thin saliva), long-time use of tobacco-like irritating and addictive products by oral route, acts as a slow poison (Dushi Visha) (tobacco properties: Tikta [bitter] and Katu [pungent taste] Rasa, Laghu [light], Tikshna [sharp], Vyavayi/Sara [diffusing in nature], Vikashi [disintegrating after spread], and Ushna (hot) guna; all the properties match with Visha (poison) induces chronic toxicity to the gastrointestinal tract such as oral diseases, Sphota (mouth ulcers), Paka, Lalima (redness), Daha (burning sensation), Ksharokshit Kshatsam (erosion of buccal mucosa), Vedna (pain), Tikta Vaktrata (bitter taste), difficulty in chewing pungent and hot things, Lasika granthi vraddhi (enlargement of sublingual and submandibular lymph nodes),[2] gingivitis, periodontitis,[3] leukoplakia (precancerous stage), recurrent apthous ulcer[4] and may lead to cancer also in advance stage. Mukhapaka is a Pitta Pradhana Sansargaja Vyadhi,[5] which may show the Pitta-dominant symptoms and associated symptoms, according to Dosha Sansarga, Vataja, Pittaja, Kaphaja, and Raktaja type. Mukhapaka resembles stomatitis in modern. The chosen formulation Triphaladi vati[6] is affirmed in Ashtanga Hridaya Sutrasthana Mukharoga Prathisheda chapter and Jatyadi gandusha[7] is affirmed in Bhaishajya Ratnavali Mukh Rogadhikar chapter, also seemed very helpful to treat the Mukhapaka. The Ayurvedic treatment regimen of Mukhapaka includes Panchakarma (Virechana Nasya, Vamana and Virechana), Yoga, external therapies (Samana Nasya, Pratisarana, Kavala (gargling), Gandusha[8] (mouth fills), Dhumapana[9], and internal medications, Advice of proper food, Activities and life style changes, we have also chosen the same type of treatment that proved very helpful in Mukhapaka treatment.

Objectives

The objective of the study is to access and compare the clinical efficacy of Triphaladi vati and Jatyadi gandusha in tobacco chewing-induced Mukhapaka.


  Materials and Methods Top


Ethical approval and registration of trail

Approval from IEC was taken before starting the trial, and consent also was taken of all patients to involve the trial. Ethical clearance No. was DSRRAU/UCA/IEC/19-20/172 dated October 18, 2019.

CTRI registration

Trial REF/2020/09/036691 has been registered. CTRI registration No. is CTRI/2020/10/028263.

Selection of trial drugs

Triphaladi vati (A.H.U.22/81-83) and Jatyadi gandusha (B.Ra. 61/92-93).

Collection of drug

Jatipatra (Jasminum officinale), Sahchar Patra (Barleria prionitis), Arimeda (Acacia farnesiana Wild), Aswatha (Ficus religiosa), and Amra (Mangifera indica) bark were collected from the RAU, Karwar Herbal Garden, after proper identification by Dravyaguna Department and other crude drugs from collected from market.

Preparation of the drug

Preparation of Triphaladi vati

All the 22 ingredients were dried and Yavkoota (coarse powder) and then mixed well. Some Yavkoota powder (½ kg) kept separate for Prakshepa (throwing powder/added substances). Yavkoota powder was 3 kg, so 24 kg water was added and boiled it well till we got 6 kg decoction and made it Ghana. Added the separated Prakshepa powder to it and then let it dry till it becomes ready to making pills/Vati. The Triphaladi ghanvati (500 mg each) was made in the pill maker machine (A.H.U.22/81-83).

Preparation of Jatyadi gandusha

The fine powder of all ingredients is made in a pulverizer machine and which is further mixed. At the time of use, Churna is mixed with Ghrit,[10] filled till the throat opening without drinking it, and hold till the whole Mukha is filled with Kapha or Kapha secretes from nose and eyes time approximately 5–10 min and repeated if patient can hold again.[11]

Administration of drug

[Table 1].
Table 1: Administration of drug

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Inclusion criteria

Diagnosed patients of Mukhapaka with history of chronic smokeless Tobacco use, age 15 and above and both sex.

Exclusion criteria

  • Tobacco-addicted patients suffering from cancer and major systemic illness such as myocardial infarction, ischemic heart disease, and pulmonary tuberculosis
  • All lesions without history of addiction of tobacco chewing
  • Syphilis, tubercular ulcer (prediagnosed cases).


Sampling technique

Patients fulfilling the inclusion criteria were selected and a simple random sampling technique was followed for grouping the patients into two groups.

Selection of patients

From the OPD of DSRRAU, Jodhpur.

The interventional phase

The clinical study was intervened by the prescribed drug, specific diet, and tobacco restrictions and meditation. This phase covers

Grouping: All 30 patients were divided into two groups

  • Group A: Fifteen patients were given Triphaladi vati.
  • Group B: Fifteen patients were given Jatyadi gandusha.


Consent of patients

All the patients after explaining the nature of treatment, their consent was obtained on patient pro forma before start the treatment.

Screening

Before treatment complete blood count (CBC) was done as a screening of patients to diagnose any abnormality such as increased ESR and WBC if any infection is there in the body so that can be excluded.

Criteria for diagnostic study were clinical examination and history.

Clinical examination was done according to Dash Vidha Pariksha, Astavidha Pareeksha, general examination, personal history, and systemic examination.

Scoring pattern

Subjective criteria

[Table 2].
Table 2: Subjective criteria

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Objective criteria

  1. Blood test - CBC
  2. ESR
  3. Photoshoots of lesions.


Criteria of assessment of patient with scoring

  1. Burning sensation


  2. 0 - No burning

    1 - Mild burning, no medicine required

    2 -Moderate burning, that subsides on cold application/medication

    3 - Severe, cannot tolerate.

  3. Number of lesions


  4. 0 - No lesions

    1 – 1–2 lesions

    2-2–5 lesions

    3 - <5 lesions.

  5. Redness


  6. 0 - No redness

    1 - Light redness

    2 - Redness

    3 - Dark redness.

  7. Pain


  8. 0 - No pain present

    1 - Mild pain, no medication required

    2 - Pain relieve on medication (painkiller/ointment)

    3 - Severe pain, unbearable, no relief on medication.

  9. Bitter taste


  10. 0 - Absent

    1 - Mild bitter taste feel, other tastes are normal

    2 - Only some tastes are normal

    3 - Cannot taste anything.

  11. Erosion of buccal mucosa


  12. 0 - No erosion

    1 - <1 cm erosion

    2-1–5 cm erosion

    3 - >5 cm area erosion.

  13. Enlargement of sublingual and submandibular lymph nodes


0 - No enlargement

1 - Lymph nodes feeling only on palpitation

2 - Lymph nodes can be seen with eyes

3 - Gross enlargement in size.


  Observations Top


Observation of demographic data

Maximum incidence of 33% was in the age group of 31–40 years, male sex 83%, Hindu 100%, married 97%, Jangala Desha 87%, middle education 60%, middle socioeconomic status 67%, labor 40%, positive family history 60%, vegetrian-nonvegetrian mix dietary habit 57%, tea and tobacco addiction 60%, Sama agni 40%, Madhyama kostha 70%, Samyaka nidra 70%, tobacco chewing history from 1 to 10 years 50%, Only gutkha chewing 40%, frequency 1–10 times per day 80%, 1–5 pouches per day 63%.

Psychological and constitutional data

Vata-Pittaja Prakruti 67%, Rajsika Manas Prukriti 87%, Madhyama Sara, Satva and Samghanana 80%, Madhyama Satmya Ahara Jarana and Abhyavaharana Shakti 77%, and Vyayama Shakti 63%.

Observation of subjective parameters

Patients were having: maximum Lalima in 27 (90%) cases, Toda in 26 (86.67%) cases, Vidaha in 23 (76.67%) cases, and followed by Ksharo-Kshit Kshtasama in 19 (63.33%) cases, then Tikta Vaktrata in 16 (53.33%) cases, then Sphota in 8 (26.67%) cases and last is Lasika granthi vraddhi seen in 3 (10%) cases.


  Results Top


Results were made using software – Graphpad software 2365 northside Dr. Suite 560, city is San Diego, California [Table 3].
Table 3: Results were made using software – Instat Graph pad 3.

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Intragroup study

[Table 4]
Table 4: Effect of therapy on the subjective parameters in (intragroup study) the 30 patients of Mukhapaka-

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[Table 5]
Table 5: Effect of therapy on the objective parameters in (intragroup study) the 30 patients of Mukhapaka-

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[Table 6].
Table 6: Showing the percentage relief and percentage change in both groups (intra group study) in subjective and objective parameters

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Inter group study

[Table 7].
Table 7: Intergroup comparison (Mann-Whitney test) on nonparametric data and (unpaired t-test) on parametric data

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  Discussion Top


It is clear from the current research project that these drugs can be used as effective drugs in Mukhapaka treatment.

Probable modes of action of Triphaladi vati

The medicinal formulation for Mukhapaka should mostly improve the quality of Rasa, Rakta, and Mamsa Dhatus and should have Deepaniya, Pachaka, Rasayana, Twagdoshahar, Hridya, Samgrahi, and Vedna Shamaka properties. Herein, Triphaladi vati sarshap, Khadir, Triphala, and Haridra helped to reduce redness, Yavkshar, Haritaki, Pippali, Shunthi, Marich, Haridra and Jamun reduced the pain, Erimeda, Haridra, and Jamun reduced burning sensation, Aswattha, Jamun Amra, and Arjun reduced the erosion, Vibhitaka and Amlvetas cured bitter taste, and Vrkshamla, Haritaki, Bhunimb, Chiytraka, Mulethi, Shunthi, Musta, Haridra, and Daruharidra helped to treat lesions [Figure 1] and [Figure 2].
Figure 1: Group- A: Before

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Figure 2: Group- A: After

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Probable modes of action of Jatyadi gandusha

Most of the drugs of Jatyadi gandusha (Punarnava, Tila, Pippali, Musta, Shunthi, Yawani, and Ghrit), having Agnivardhaka, Deepana, Pachana, Rasayana, Brimhaniya, Jeevaniya, Balya, Ojovardhaka, Ayuvardhaka, and Dhatuposhaka properties. Punarnava, Tila, and Musta reduced redness. Jati, Pippali, Shunthi, Yawani, and Haritaki proved to be pain-reducing, Ghrit reduced burning sensation, Jati, Punarnawa, and Ghrit reduced skin erosions, Vacha and Shunthi reduced bitter taste, Jati, Pippali, Sahchar, Musta, Yawani, and Haritaki helped to treat lesions, and Tila reduced lymph nodes enlargement. Haritaki, Yawani, Sahchar, Tila, and Jati are used in Mukha rogas in earlier studies. Goghrita is Madhura in Rasa, Guru, Snigdha in Guna, Sheeta in Veerya and Madhura in Vipaka. It is also have Rasayana, Balya, Deepaniya, and Ojovardhaka. Gandusha is already a chosen and proven treatment of Mukhapaka [Figure 3], [Figure 4].
Figure 3: Group- B: Before

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Figure 4: Group- B: After

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  Conclusion Top


Conceptual study

Tobacco causes Ojakshaya, acts as a slow poison (Dushi Visha), causes systemic effects (Daurbalya, Jathragni Mandhya) and local (oral diseases) such as teeth decay and discoloration of teeth which loses the beauty of face; also, the lesions, pain, burning sensation, and erosion of buccal mucosa make life very miserable. The chosen drug formulations are found very effective in Mukhapaka treatment.

Clinical study

  • Triphaladi vati and Jatyadi gandusha both are effective in the management of Mukhapaka (stomatitis). Both definitely reduce the symptoms of Mukhapaka that include Daha, Lalima, Tikta Vaktrata, Ksharokshit Kshatasam mainly followed by, Peeda (pain), Sphota, and Lasika granthi vraddhi
  • When percentage relief in subjective criteria in both groups is compared, it is clear that Group B (Jatyadi gandusha - 81.44%) had slightly better results than Group A (Triphaladi vati - 72.83%), both formulations are significantly effective for Mukhapaka treatment so can be used for Mukhapaka treatment.


Acknowledgment

I acknowledge my gratitude to my Guide Dr. Ritu Kapoor Mam and my institute Dr. Sarvepalli Radhakrishnan, RAU, Jodhpur, for granting me permission and facilities provided me to carry out this study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.





 
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Dhiman A, Kumar P, Dhiman A. Role of ayurveda in management of mukhpak(stomatitis) –A review article. International Ayurvedic medical Journal {online} 2016 Available from: http://www.iamj.in/posts/images/upload/3464_3467.pdf. [cited 2021 Dec 28].  Back to cited text no. 9
    
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]



 

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