Addyzoa Summary of Product Characteristics (SPC)

1. Addyzoa capsules
a) All ingredients present in the formulation:
Each capsule contains:
Name of Ingredient Latin/ English Name Qty
Powders :
Purnachandrodaya rasa >>>> 45 mg
Muktashukti bhasma Pearl Oyster Shell Calx 30 mg
Suvarnamakshik bhasma >>>> 30 mg
Shilajit shuddha Purified Asphaltum 30 mg
Abhrak bhasma Mica (Calcined) 30 mg
Makardhwaj rasa >>>> 15 mg
Rasa sindur Mercuric Sulphide 15 mg
Dry extract of the following :
Puncture Vine Tribulus terrestris 200 mg
Ashtavarga >>>> 200 mg
Indian Spider Plant Chlorophytum arundinaceum 150 mg
Purified Cow-Itch Plant Purified Mucuna pruriens 150 mg
Heart Leaved Moonseed Tinospora cordifolia 150 mg
Winter Cherry Withania somnifera 150 mg
Indian Gooseberry Emblica officinalis 75 mg
Country Mallow Sida cordifolia 75 mg
Hawaiian Baby Woodrose Argyreia speciosa 75 mg
Asparagus Asparagus racemosus 75 mg

2. Polynesian Arrowroot Tacca aspera 30 mg
China Root Smilax china 30 mg
Sweet Potato Ipomoea digitata 30 mg
Orchid Eulophia campestris 15 mg
Besides medicinal plants, a number of Ayurvedic formulations are known to contain
inorganic substances like mercury, arsenic, lead, zinc, tin, iron, sulfur and copper.
Herbo-metallic Ayurvedic preparations can be bhasma (powder of a substance obtained
by calcinations; mainly applied to metals and minerals), rasa-yoga (preparations
containing minerals as main ingredients; the minerals may be mica, copper-pyrites, or
elements like gold, silver or copper), and rasa aushadhi (preparations containing metals
and minerals). Since metals maybe toxic in their native forms, classical Ayurveda
describes methods for detoxification of both metals and minerals.
Ayurveda explains bhasma as anything organic or inorganic incinerated into its ash (3).
These are generally end products of incineration process. The starting material
undergoes an elaborate process of purification (shodhana). This process is followed by
the reaction phase, which involves incorporation of some other mineral and herbal
extracts. Then the material in pellet form is incinerated in a furnace. The end product is
expected to be non-toxic material.
Traditionally Bhasmas have been indicated for various disorders such as Loha Bhasma
(Iron oxide) in anemia, Muktashukti Bhasma (consisting of Pearl, Aloe Vera and Lime
juice) as anti inflammatory and Abhrak Bhasma (Mica) as Hepatoprotective.
Poorna chandrodayam (Purnachandrodaya rasa or PC) is an elixir of mercury and gold
widely used in Siddha Medicine prepared by kupi pudam process. It is a bright scarlet
red coloured powder, soluble in Aqua regia. Content of gold, mercury and sulphur
were found to be 9.78, 78.11 and 11.95 g, respectively and 280 ppm of free mercury. The
studies confirms that PC is converted into an amalgamation process and mostly present
as Mercury sulphide along with gold and a small portion of mercury oxide. Aqua regia
(lit. "royal water"), aqua regis (lit. "king's water"), or nitro-hydrochloric acid is a highly
corrosive mixture of acids, a fuming yellow or red solution. The mixture is formed by
freshly mixing concentrated nitric acid and hydrochloric acid,[1] usually in a volume
ratio of 1:3. It was named so because it can dissolve the so-called royal or noble metals,
gold and platinum.
Muktashukti bhasma (MSB) is an Ayurvedic compound, consisting of Purified Pearl
Shell (1 part), Aloe Vera Juice (Q.S.) and fresh Lime Juice (Q.S.).

3. Method of Processing
Purified Pearl Oyster Shells are transferred to a vessel half-filled with Aloe Vera juice.
Pearl Oyster Shell pieces are placed over the thick juice and the remaining space in the
vessel is again covered by adding Aloe Vera juice. The vessel is sealed and given a
Gajput (refer glossary). On cooling Pearl Oyster Shell pieces are removed and blended
with fresh lime juice in a flat surfaced vessel. The mixture is rolled into a cake and
dried. The dried cake is again given a Gajput to obtain soft - butter like Mauktik-Shukti
Bhasma (Pearl Oyster Shell Calx). Pearl oyster Calx is then processed in cow's milk or
Chandanaadi Ark, dried and stored.
Gajput: It is heated in absence of air in 800 – 900 degree Celsius for 2 – 3 hours. This
process is repeated for three times, to get white colored Muktasukti Bhasma (Pearl
Oyster Calx)
Suvarnamakshik bhasma is an Ayurvedic compound, consisting of Purified Copper
pyrite (1 part), and fresh Lemon Juice (Q.S.).
Shilajit shuddha English name: Asphaltum Traditional Uses: Analysis of Shilajit
reveals that it is high in naturally occurring minerals and elements. Shilajit is Mother
Nature's original organic Colloidal multi-mineral supplement with self assimilation
qualities as compared to inorganic colloidal sources. And yet Shilajit is much more than
colloidal minerals. It has unique properties not found in any other natural preparation.
There is a folk saying by the indigenous people who live in the Himalayan region that
Shilajit makes the body strong as a rock and there some rock-like qualities in Shilajit.
There is hardly a disease that cannot be cured or least helped by Shilajit. Shilajit
amplifies the benefits of other herbs by enhancing their bio-availability. It helps
transport nutrients deep into the tissue and removes deep-seated toxins. Shilajit
improves memory and the ability to handle stress. Shilajit reduces recovery time in
muscle, bone and nerve injuries. Shilajit stimulates the immune system and reduces
chronic fatigue. It is an adaptogen, (Rasayna), that helps to combat immune disorders,
urinary tract disorders, nervous disorders and sexual dissatisfaction.
Abhraka Bhasma (Purified Mica) is triturated with various herbal water decoctions
and juice extracts, made into thin disc shaped cakes, and subjected to 800 – 900 degree
Celsius heat. The process is repeated for several times. The end product will be a very
fine powder. If it is repeated for 100 times, it is known as Shataputi Abhraka Bhasma.
Chemical composition: It contains Magnesium, Iron, Potassium, Calcium and
Aluminium.
Makardhwaj rasa: Purified Swarn Gold pieces 11.6638038 grams are blended with
Purified Mercury and Purified Sulphur in the ratio of 1:2:4 and thoroughly blended for
6-7 hours every day over a period of 7 days to form Black Sulphide of Mercury (The

4. greater period the mixture is blended the better quality is obtained). Black Sulphide of
Mercury is then treated with the red flowers of Bombax ceiba (Cotton Tree) juice and
Aloe Vera juice 3 times each. The mixture is dried and transferred to a glass flask. The
flask is layered 7 times with cloth plastered with wet-mud/clay is cooked in a sand and
gadget apparatus (see below) for 24hours. On cooling red-coloured Makardhwaj is
collected.
In classical Ayurveda formulations, makardhwaj is used as a sexual stimulant and
vitalizer (Sinyorita et al., 2011) and is never used by itself but always used in
combination with medicinal plants.
Rasa sindura or Mercuric Sulphide: Take of mercury and sulphur equal parts, and
prepare Rasa sindura as already described by sublimation in a glass bottle.
Ashtavarga (group of eight medicinal plants):
1. Malaxis muscifera, The Fly Bearing Makaxis (Medicinal Orchid) - Increases
seminal fluid.
2. Malaxis acuminate, The Gradually Tapering Malaxis (Medicinal Orchid) -
Aphrodisiac
3. Polygonum verticilliatum, Polygonaceae Rhizome - Increases seminal fluid.
4. Polygonum cirrifolium, Polygonaceae Rhizome - Increases seminal fluid.
5. Roscoea procera, Ginger Root - Aphrodisiac
6. Fritillaria royeli, Liliaceae Root - Tonic
7. Habenaria intermedia, Wild Orchid (Medicinal Orchid) - Tonic and increases
seminal fluid
8. Habenaria edgeworthii, (Medicinal Orchid) - Tonic and increases seminal fluid
Additional ingredients: Sodium Methyl Paraben, Sodium Propyl Paraben
b) Dose, Dose Schedule, Route of administration:

5. Dosage:
Tablet
Adult: Sperm count 5 millions/ml to 10 millions/ml : 2 capsules twice a day for
90 days. Sperm count > 10 millions/ml : 1 Capsule twice a day for 90 days.
It is recommended to go for a repeat sperm count at least 6 wks after start of
treatment; as that is the time spermatozoa takes to become a mature sperm.
Dosage of addyzoa is 2 capsules thrice a day for 90 days; but it takes at least 6
weeks for the results to show. Studies have proven that regular sex is better for
pregnancy than timed intercourse. You can have sex while on Addyzoa therapy.
Oral
c) Therapeutic/diagnostic claims:
Male Functional Infertility-Oligo, Asthno and Teratospermia
Benefits
1) Increases Sperm Count
2) Enhances Sperm motility
3) Improves Sperm Morphology (prevents DNA damage to sperms)
4) Enhances the chances of pregnancy
5) Increases sexual desire.
d) Description of dosage form being registered:
100 CAPSULES (05 STRIPS OF 20 CAPSULES)
Approved colours used in empty gelatin capsules.
e) Pharmacological properties.
Pharmacodynamics.
THERAPEUTIC RATIONALE
ADDYZOA is a herbomineral spermatogenic antioxidant. ADDYZOA has
multifaceted free radical scavenging action and therefore, ADDYZOA minimizes

6. effectively the damage to the sperm cells due to reactive oxygen species (ROS). ROS
(reactive oxygen species) are molecules that play a role in male factor infertility.
Addyzoa effectively minimises this damage to the sperm cells due to ROS. Withania
somnifera, Tinospora cordifolia and Emblica officinalis are potent antioxidants in
ADDYZOA, which act by reducing the excessive oxidative stress, which is
responsible for sperm damage. Shilajit shuddha, Mucuna pruriens shuddha and
Withania somnifera improve sperm count. Asparagus racemosus increases
spermatogenesis by regeneration of seminiferous tubules. Thus, ADDYZOA
improves sperm count, motility and morphology and also increases semen density.
ADDYZOA has been widely used for the empirical treatment of male infertility for
more than 3 decades, has only been sporadically evaluated in this condition. According
to Thakre and Thakre, this herbo-mineral preparation improved the quality and
quantity of semen by increasing sperm count and motility. Treatment with Cow-Itch
significantly improved testosterone (T), LH, dopamine,adrenaline, and noradrenaline
levels in infertile men and reduced levels of FSH and PRL. Sperm count and motility
were significantly recovered in infertile men after treatment. Treatment with M.
pruriens regulates steroidogenesis (production of steroids by the adrenal glands) and
improves semen quality in infertile men. Antioxidants present in Addyzoa such as
Vitamin-C from Amla (Indian Gooseberry) and Ashwagandha( Winter Cherry), help to
restore the properper oxidant; antioxidant balance, thus maintaining the genetic
integrity of sperm cells by preventing oxidative damage to sperm DNA. Asparagus
recemosus, present in the dose of 25 mg may help in regeneration of seminiferous
tubules and thus cause an increase in spermatogenesis.
Action
Clinical Pharmacology
Spermatogenesis: Purnachandrodaya rasa, Makardhwaj rasa,
Eulophia campestris, Mercuric Sulphide,
Suvarnamakshik bhasma, China Root, Sweet
Potato, Indian Gooseberry, India Spider Plant,
Cow-Itch, Winter Cherry, Puncture Vine,
Country Mallow
Nervine Tonic & Tranquilizer: Asparagus, Winter Cherry, Abhraka Bhasma,
Suvarnamakshik, Muktashukti bhasma
Nutritive: Tacca aspera, Hawaiian Baby Woodrose, Sweet
Potato, Country Mallow, Winter Cherry

7. Rejuvenator: Indian Gooseberry, Heart-Leaved Moonseed,
Asparagus, Winter Cherry
Premature ejaculation & oligospermia: Indian Spider Plant
Improves sperm count: Asphaltum, Cow-Itch
Antioxidant &protects sperm from ROS: Heart-Leaved Moonseed, Indian Gooseberry
Antioxidant, sperm count, sperm motility: Winter Cherry,
f) Pharmacokinetics. Whereas Addyzoa® is a multicomponent preparation, its kinetics
caused by an additive effect of its components and conducting trials is impossible.
Actions: Addyzoa® Increases Sperm Count, enhances sperm motility, improves sperm
morphology (prevents DNA damage to sperms), prevents premature ejaculation,
enhances the chances of pregnancy and acts as an aphrodisiac.
g) Contraindication/precautions:
Use only under medical supervision.
Drugs interactions:
It is generally recommended to take Addyzoa alone. However, in practice for
cases of severe oligoasthenospermia, Addyzoa can safely be administered with
the Drug Clomid.
h) Adverse effects:
The drug was well-tolerated and there were no adverse effects in either group.
No adverse effects were reported during the treatment.
i) Symptoms of Overdose:
Nausea and vomiting
j) Treatment of Overdosage:
Stomach wash and symptomatic treatment

8. k) Toxic effects, and protocol for treating toxicity or where applicable, antidote.
The drug was well-tolerated and there were no adverse effects in either group.
No adverse effects were reported during the treatment.
The result of acute toxicity studies conducted by K.M. Kundanani College of
Pharmacy clearly indicates that there were no toxic effects or deleterious
reactions of any clinical significance induced by Addyzoa Capsules in mice by
oral route. Refer to Toxicity Studies Dossier for details.
l) A. Shelf life:
Shelf life of Addyzoa is 36 months from the date of manufacturing.
B. Storage conditions:
Keep it out of reach of children. Store in a dry place; away from direct sunlight
at the temperature not more than 25º С.
m) Presentation and pack size: Blister Packs conveniently presented for patient
use. ___________________________________________________?
n) Manufacturer:
CHARAK PHARMA PVT. LTD.
o)