The Efficacy of Soubhagya Shunthi Granules as an Analgesic in Episiotomy and other Aspects of Puerperium

Keywords:
Analgesia, Soubhagya Shunthi Granules, Vaginal delivery with episiotomy

Background:
Maternal health refers to the health of women during pregnancy, childbirth, and the postpartum period. In Ayurvedic Samhita actions of herbal medicines are elaborated in detail, by all acharyas. Soubhagya Shunthi Granules are advised by Acharya in Sutikavastha (puerperal phase).1 Shunthi (Zinziber Officinale) is the main active drug in this combination. And all other drugs in this formulation belong to Charkopta SHULPRASHAMAN Gana i.e. group of drugs with analgesic property. So in this study this combination will be studied for its analgesic action. So, Soubhagya Shunthi Granules were selected for this study.

Methodology:
· Randomized, single blind study of 100 patients in 2 groups was done.
· Group A 50 patients were given Soubhagya Shunthi Granules.
· Group B 50 patients were given Paracetamol.

Results:
Comparing the assessment criteria before and after treatment, Soubhagya Shunthi Granules had significant action as analgesic in Episiotomy pain and other aspects of puerperium.

Conclusion:
Aim of this study was to establish, analgesic action of Soubhagya Shunthi Granules. This was proved by data collection. Along with this, Soubhagya Shunthi Granules also proved to be good glactogauge and Appetizer.

Introduction
Maternal health refers to the health of women during pregnancy, childbirth, and the postpartum period. It encompasses the health care dimensions of family planning, preconception, prenatal, and postnatal care in order to reduce maternal morbidity and mortality. In Ayurvedic Samhita actions of herbal medicines are elaborated in detail, by all Acharyas. Efficacy of single herb is improved by processing or combining herbs together. Many Ayurvedic practitioners use different Ayurvedic formulations for pain relief. Research was done on Analgesic (Pain killer) action of Zinziber Officinale (Shunthi) by A Journal of American Society’s “THE JOURNAL OF PAIN” VOL-II 10thSeptember 2009-2010. It has described the action of Zinziber Officinale as moderate to severe pain reliever in muscle pain.

Soubhagya Shunthi Granules are advised by Acharya in Sutikavastha (puerperal phase). Shunthi(Zinziber Officinale) is the main active drug in this combination.And all other drugs in this formulation belong to Charkokta SHULPRASHAMAN gana i.e. group of drugs with analgesic property. So in this study this combination will be studied for its analgesic action.

Episiotomy is a Surgical incision of the perineum to enlarge the vagina and to facilitate delivery during childbirth thus perineal muscles are incised, so there is muscle pain which is to be relieved during puerperal stage.

The term Sutika is used for a women in labour after aparapatan (Expulsion of placenta). Though pregnancy & delivery are physiological states, female body goes through a series of Anatomical, Physiological and Psychological changes.

The women becomes weak or emaciated (kshapit) due to development of foetus & empty bodied (Shithil) due to unsteadiness (dhatukshaya), labour pains excretion of kleda & blood. During puerperal period she regains all the lost things & reaches her pre-pregnant stage. During puerperal stage she may land into disease condition even due to minimum Mithyachar (wrong diet & life style).
For this purpose Granthakar’s have advised different types of lifestyle (Snehan, Swedan, etc.) & diet (Taila & Ghrita pan) even some herbal preparations like Soubhagya Shunthi Pak , to balance Dosha , Dhatu Mala for healthy status.

This study is a trial to validate analgesic action of herbal medicine containing Shunthi as a main component. So Soubhagya Shunthi Granules have been selected for study.

Aims and Objectives

Aims
1) To compare the analgesic (shoolhar) effect of Soubhagya Shunthi Granules and paracetamol in Episiotomy wound in puerperium.
2) To study the effect of Soubhagya Shunthi Granules in improvement of lactation & uterine involution in puerperium.

Objectives
1) To study the effect of soubhagya shunthi granules as analgesic
2) To study the action of soubhagya shunthi granules on other aspects of puerperium i.e. lactation, digestive power, wound healing.

Materials & Methods
1] Selection of Patients –
A] Inclusion Criteria –

1. All patients were vaginal delivery with episiotomy including forceps and ventouse delivery.
2. Only primi para patients.
3. Anaemic patients were also included.

B] Exclusion Criteria -
1. Multipara patients
2. Patient who’s baby is not alive (IUD)
3. Patient with neonatal death of baby.
4. Gestational diabetes

2] Type of study – Single Blind randomized study.
3] Form of drug :Granules
4] Route of administration:Oral
5] Dose:
  · Group A: Soubhagya Shunthi Granules 40 gm. (1 pal) i.e. 20 gm/ twice a day
  · Group B: Paracetamol 0.5g /thrice a day
7] Anupan :Luke warm water
8] Number of patients:
  · Group A - 50
  · Group B - 50
9] Type of study: Single blind randomized study

50 patients were enrolled in each group.
· Group A patients were given SOUBHAGYA SHUNTHI GRANULES from postpartum 1st day to 7th day 20 gm Twice a day and follow up was taken daily for first 7 days
· Group B patients were given Tab. Paracetamol 500mg thrice a day from postpartum 1st day to 7th day and follow up was taken daily for first 7 days.

Observations
1. Episiotomy Pain
It was observed in group A,
· Thirty-four patients (68%) had moderate pain and sixteen patients (32%) had mild pain in first 24 hours.
· Pain gradually increased on day second & third day but was tolerable.
· Again Pain subsided from fifth day.
· Only twelve patients (24%) needed alternative medicine.
· In remaining fourty patients (80%) pain was tolerable.
· Till day seven of treatment thirty-one patients (62%) had mild pain, fifteen patients (30%) had moderate pain and four patients (8%) had severe pain.

Similarly it was observed that in group B,
· Twenty-two patients (44%) had moderate pain and twenty-seven (54%) patients had mild pain in first 24 hours.
· Pain gradually subsided from second to fifth day.
· Till day seven of treatment fouty-seven patients (94%) had mild pain, two patients (4%) had moderate pain and one patient (2%) had severe pain.

A) Episiotomy Pain Accoyding to Prakruti

It was observed in group A that,
· In Kapha-Pitta prakruti, out of thirteen (26%) nine patients (18%) experiencedmoderate pain & four patients (8%) experienced mild pain.
· Only three patients (6%) in this group needed alternative medicine.
· In Pitta-Kapha prakruti, out of three patients (6%)two patients (4%)experiencedmoderate pain& one patient (2%)experienced mild pain.
· Only one patient (2%) in this group needed alternative medicine.
· In Pitta-Vata prakruti, out of seventeen (34%) fourteen patients (28%)experiencedmoderate pain &three patients (6%) experienced mild pain.
· Only four patients (8%) in this group needed alternative medicine.
· In Vata-Kapha prakruti, there was single patient (2%) andexperienced moderate pain.
· In Vata-Pitta prakruti,out of sixteen (32%)eight patients (16%) experienced moderatepain &eight patients (16%) experienced mild pain.
· Only four patients (8%) in this group needed alternative medicine.

Similarly in group B,
· In Kapha-Pitta prakruti, out of nineteen (38%) five patients (10%) experienced moderate pain &fourteen patients (28%) experienced mild pain.
· In Kapha-Vata prakruti there was single patient (2%) and experienced moderate pain.
· In Pitta-Kapha prakruti, out of four (8%) three patients (6%) experienced moderate pain&one patient (2%) experienced mild pain.

· In Pitta-Vata prakruti, out of eighteen (36%) ten patients (20%)experienced moderate pain& eight (16%)experienced mild pain.
· In Vata-Kapha prakruti, out of two patients (4%)one patient (2%)experienced moderate pain&one patient (2%) experienced mild pain.
· In Vata-Pitta prakruti, out of six patients (12%) two patients (4%)experienced moderate pain& four patients (8%)experienced mild pain.

A) Episiotomy Pain According to Age
In group A it was observed that,
· In age group 18-24 out of fourty-two patients (84%), twenty-nine patients (58%) experienced moderate pain & thirteen patients (26%) experienced mild pain.
· In age group 24-30 out of eight patients (16%) five patients (10%) experienced moderate pain & three patients (6%) experienced mild pain.

Similarly in group B,
· In age group 18-24 out of thirty-eight patients (76%) eighteen patients (36%) experienced moderate pain & twenty patients (40%) experienced mild pain.
· In age group 24-30 out of twelve patients (24%) one patient (2%) experienced severe pain, four patients (8%) experienced moderate pain & seven patients (14%) experienced mild pain.

2. Episiotomy Wound

It was observed that in group A out of fifty patients,
· Fourty-eight patients (96%) had healthy wound and two patients (4%) had rednessin first 24 hours.
· There wereall four signs of inflammation in twelve patients (24%) from third to fifth day. Thus, added Paracetamol along with Soubhagya Shunthi Granules.
· Thirty-eight patients (76%) had redness & pain from second day which subsided by fifth day of treatment.
· Till day seven of treatment fourty-sixpatients (92%) had healthy wound and four patients (8%) had redness but wound was healthy.
It was observed that in group B,
· Fourty-nine patients (98%) had healthy wound and one patient (2%) had pain & redness on first day.
· From third day it gradually reduced.
· Till day seven of treatment fourty-nine patients (98%) had healthy wound and one patient (2%) had redness but wound was healthy.
Thus, it can be stated that there was significant improved wound healing process in both groups.

3. Breast Secreations

It was observed that in group A out of fifty patients,
· Twenty patients (40%) Breast secretions were started within 24 hours of treatment.
· Twenty-eight patients (56%) secretions were started on second day.
· Single patient (2%) on day third day.
· One patient needed Shatavari Kalp.

Similarly in group Bout of fifty patients,
· One patient (2%) Breast Secretions were started within 24 hours.
· Fourty patients (80%) secretions were started on second day
· Nine patients (18%) breast secretions were started on third day.

This observation was done on the basis of top feeds required to neonates. Top feeds were not required to twenty neonates (40%) of group A but, it was required to fourty-nine neonates (98%) in group B. Thus, fast result was observed on Breast Secreations in group A.

4. Uterine Involution

As Uterine Involution is a Physiological Process, it was again observed in this study.

5. Agni Deepan

It was observed that in group A,
· Within twenty-four hours of treatment, thirty-two patients (64%) had mandagni, eighteen patients (36%) had madyam agni & ten patients (20%) had prakrut (uttam) agni.
· From second day remarkable Agni Deepan was observed till seventh day.
· Till day seven of treatment, twelve patients (24%) had madyam agni and 38 patients (76%) had prakrut (uttam) agni.
Similarly in group B,
· Thirty-seven patients (74%) had mandagni, eleven patients (22%) had madyam agni& two patient (4%) had prakrut (uttam) agniin first 24 hours.
· Till day seven, two patients (4%) had mandagni seventeen patients (34%) had madyam agni and thirty-one patients (64%) had prakrut (uttam) agni.
Thus it is seen that in group A agni deepan was enhanced from second day of treatment. It was poor in group B.

6. Lochial Discharge

A) Quantity
It was observed that in group A,
· Fourty-eight (96%) patients needed three pads per day & two patients (4%) needed four or more pads in first twenty-four hours.
· Tillday Seven eighteen patients (36%) needed only one pad & thirty-two patients needed two pads per day.
Similarly in group B
· Fourty-seven patients (94%) needed three pads per day, two patients (4%) needed two pads per day& one patient (2%) needed four or more pads infirst twenty-four hours.
· On day seven thirty-five patients (70%) needed only one pad per day& fifteen patients (30%) needed two pads per day.

B) Colour
It was observed that in both groups Yonistrava was Rakta Varni till day six & in few patients it was Peet Varni on day seven.

Discussions

1. Episiotomy Pain
- Soubhagya Shunthi Granules is a formulation containing Shunthi as main component. According to research in “ THE JOURNAL OF PAIN” VOL-II 10th september 2009-2010 Shunthi is described to act as muscle pain killer. All other drugs of this formulation are katu, katu, ushna so they act as Deepan and Pachan. Also all drugs of this formulation belong to Charkokta Sulhar Gana.
- This was a study to observe mainly analgesic action of Soubhagya Shunthi Granules. And it showed moderate analgesic action. This may be because many drugs of this formulation are Vata-Kaphaghna. And many drugs are ushna viryatmak.Main component Shunthi is Katu, Madhur, Ushna.
- Main action of Soubhagya Shunthi Granules is on agni, by correcting mandagni of sutikawastha it results good as an analgesic.

A) Prakrutiwise Distribution

· In Prakruti wise distribution of Episiotomy Pain as observation showed moderatepain in patients of Pitta-Vata, Vata-Pitta& Kapha-Pitta Prakruti in both groups, this may be due to Dhatu Kshaya janya &Kleda nistruti janyaVata prakop of sutikawastha, in addition to Pitta pradhan awastha due to age.
· Soubhagya Shunthi Granules by its katu rasa, katu vipak & Ushna virya act as Vataghna.
· Thus, moderate pain relief was observed in patients with Vata-Pitta & Pitta-Vata prakruti.

B) Agewise Distribution

· In India general age of marriage is 18-24 which was again observed in this study.
· This age is Pitta pradhan awastha, Pitta in accordance with Vata of Sutikawastha causes more pain which gradually reduces in higher age groups in both groups A and B.

2. Episiotomy Wound (Yoni Vrana)

- In both groups Wound Healing process was similar. But, mode of action of wound healing process is different.
- Praracetamol will reduce local inflammation and thus, result in proper wound healing.
- But total composition of Soubhagya Shunthi Granules improved Dhatu Saratva (nutrition) and resulted into enhancing wound healing process.
- Malnutrition is observed in 70-80% of Indian population. As Soubhagya Shunthi Granules result good in wound healing well, this shows it covers malnutrition.
- This may be due to katu, katu, ushna action of many drugs that act as deepan pachan and ultimately result in wound healing. Also Shunthi is anti inflammatory so resulted in good wound healing.

3. Breast Secreations

- Soubhagya Shunthi Granules resulted in fulfilment of baby’s nutrional needs on first & second day post partum in 96% patients.This may be due components like Gou dugha which is sadhyo stanyavrudhikar, Gou-Ghrita which improves rasa dhatwagni that ultimately nourishes Sutika leading to stanya nirmiti by Khalekapot Nyaya.
- In addition to that Shatahva, Lavanga, Mustak which act directly as Stanyajanan.

4. Uterine Involution
· Uterine Involution is a physiological process. It cannot be suppressed or enhanced by any means. If it is so, it indicates infectious condition. So, here in this study there is no significant pre or post change in Uterine Involution hampering normal physiological action.

5. Digestive Power (Agni)

- Soubhagya Shunthi Granules is a formulation containing maximum Drugs of Katu rasa, Katu vipak & Ushna virya. So all drugs have Agni deepan & Pachan property. Ultimately they act good on Digestive Power. And bring Manda Agni of sutikawastha to prakrut very early.
- Shunthi is the main drug of this formulation, it corrects the the kleda nisruti in sutikawastha by its ruksha & ushna guna. Thus results in agni deepan
- This is the main action of Soubhagya Shunthi Granules, that it makes Vata Prakrut & corrects Agni mandya & thus results on all of its properties including analgesic action on Episiotomy pain.

6. Lochial Discharge (Yoni Strava)

Quantity And Colour (Pramana And Varna)
· Yoni Strava Pramana and Varna were both similar in both groups because, shedding of decidua after delivery is also a physiological process.
· In normal labour shedding of endometrium (decidua), lochial discharge & Uterine Involution are all physiological processes.

Conclusion

Soubhagya Shunthi Granules were selected for this study mainly to study its analgesic action on muscles i.e on Episiotomy Pain. But as all components of this drug act to overcome all factors of purperium like Agni Mandya, Dhatu Kshya Janya Vata prakopa, Stanja Janan, etc. All other aspects were also studied.

The following conclusions were drawn after completeting the study:

· Random selection of patients was done.
· Soubhagya Shunthi Granules showed moderate result on Episiotomy Pain but pain was tolerable in 76% patients.
· In Prakrutiwise Disribution it gave good result in patients of Pitta-Vata Prakruti & Vata-Pitta.
· Soubhagya Shunthi Granules showed moderate action on Wound Healing process.
· Soubhagya Shunthi Granules resulted good as Stanya Janan as compared to Group B.
· Soubhagya Shunthi Granules is a good galactogouge & thus beneficial to neonate, which will protect neonate from side effects of top feeds.
· As Uterine Involution is a Physiological Process, it resulted according to physiology.
· Soubhagya Shunthi Granules resulted very good as Agni Deepan. By this property it acted good in above all aspects.
· Yoni Strava Pramana & Varna were both as per physiology in both groups.

Aim of this study was to establish, analgesic action of Soubhagya Shunthi Granules. This was proved by data collection. Along with this, Soubhagya Shunthi Granules also proved to be good glactogauge and a good Appetizer.

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